A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus

Time frame

Day 1 through Day 84

Measure

LEAST_SQUARES_MEAN · NRS Pain Score

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants will be asked to report their maximum daily pain using the NRS-Pain. Participants will call into an interactive voice response e diary system (IVRS) and record the number that best reflects their maximum amount of pain experienced in the last 24 hours. Participants will be asked to call at the same time each day, preferably before bedtime. Longitudinal trends over the course of the treatment period will be modeled and used to estimate difference between means at baseline and Day 84 for each treatment group.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug. One participant, in the Medium: JBT-101 20mg/Placebo treatment, took one dose of drug in clinic and subsequently decided to discontinue treatment and terminate the study. This participant did not report a pain NRS score on Day 1 and is therefore not included in this analysis.

Time frame

Visit 1 (Baseline)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Baseline.

Time frame

Visit 3 (Day 29)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 3 (Day 29).

Time frame

Visit 4 (Day 57)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 4 (Day 57).

Time frame

Visit 5 (Day 85)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 5 (Day 85).

Time frame

Visit 6 (Day 113)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 6 (Day 113).

Time frame

Visit 3 (Day 29)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 3 (Day 29).

Time frame

Visit 4 (Day 57)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 4 (Day 57).

Time frame

Visit 5 (Day 85)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 5 (Day 85).

Time frame

Visit 6 (Day 113)

Measure

COUNT_OF_PARTICIPANTS · Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The Improvement Pain Category is the change in the pain category from baseline to the post-baseline visit. An improvement of at least 2 pain categories from baseline is considered major pain improvement; improvement of 1 pain category, improvement; no change in pain category, no change; worsening of at least 1 pain category, worsening.

Population: The modified intent-to-treat population includes all randomized participants who received at least one dose of study drug and had data at Visit 6 (Day 113).

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

NUMBER · Percentage of Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.

Population: mITT: The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

NUMBER · Percentage of Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

NUMBER · Percentage of Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

NUMBER · Percentage of Participants

Reporting status

POSTED

The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. The percent change from baseline in the 7-day average of the maximum NRS-Pain scores prior to study Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment

Measure

MEAN · Number of Tender Joints

Reporting status

POSTED

The change from baseline in the number of tender joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of tender joints can range from 0 to 68 joints.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Baseline, (Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Number of Swollen Joints

Reporting status

POSTED

The change from baseline in the number of swollen joints identified by the physician in the Physician Joint Exam at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The number of swollen joints can range from 0 to 66 joints.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

NUMBER · Percentage of Participants

Reporting status

POSTED

The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The percentage of participants with arthritis indicated as Present on the SELENA SLEDAI at Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. \[A single question on the SELENA SLEDAI with a response of Present or Absent was assessed.\]

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit."

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

NUMBER · Percentage of Subjects

Reporting status

POSTED

The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. The severity of arthritis at baseline will be determine by the highest arthritis severity level where arthritis is indicated as improving, same, new or worse\* BILAG-2004: British Isles Lupus Assessment Group 2004. The percentage of participants who met the criteria for improvement of arthritis in the BILAG-2004 Musculoskeletal assessments (using the mild, moderate and severe arthritis questions on the assessment) at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

NUMBER · Percentage of Subjects

Reporting status

POSTED

The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index \[SELENA-SLEDAI\], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. A responder is defined as having at least a 4 point reduction in the SELENA-SLEDAI score, no new BILAG A or no more than 1 new BILAG B domain score, and no increase in the PGA of 0.3 points or more. The percentage of participants who met the criteria for a responder in the SRI at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Scores on a Scale

Reporting status

POSTED

The change from baseline in the SELENA-SLEDAI score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed. The Safety of Estrogen in Lupus National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a validated tool for assessing SLE disease activity. The SLEDAI is a one page assessment that contains 24 items scored as present or absent. Each item is assigned a weighted score which is summed to calculate the overall SLEDAI score. SLEDAI score ranges from 0-105 points. Higher scores represent more disease activity, with a score of 6 being considered clinically important and may impact the decision to treat.

Population: mITT -The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Score

Reporting status

POSTED

For each of the nine domains, a numerical score will be assigned based on the BILAG score as follows: A=12, B=8, C=1 and D/E=0. A single numerical BILAG total score will be calculated for each participant visit as the summation of the numerical scores for each of the nine domains. The BILAG total score can range from 0 to 108, with higher scores indicating more disease activity. The change from baseline in the total BILAG-2004 score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Score

Reporting status

POSTED

The change from baseline in the total PGA score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The PGA utilizes a 0 to 3 visual analogue scale for assessing disease activity in SLE that is anchored by the verbal descriptors as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. An increase of \>=0.3 points is considered worsening of the PGA.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment) and Visit 6 (Day 113)

Measure

MEAN · Score

Reporting status

POSTED

The change from baseline in the total Patient Global Assessment score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed. The total Patient Global Assessment is performed with a visual analogue scale (0 to 100) in which the participant is asked to indicate how active she/he thinks their disease is. The visual analogue scale is anchored by two descriptors: "not active" (score of 0) and "extremely active" (score of 100).

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · T-Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better functioning for the Physical Function domain. The change from baseline in the PROMIS-29 Physical Function T-score at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85).

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · T-Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Anxiety T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Anxiety domain. The change from baseline in PROMIS Anxiety Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Depression T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Depression domain. The change from baseline in PROMIS Depression Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · T-Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Fatigue T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Fatigue domain. The change from baseline in PROMIS Fatigue Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Sleep Disturbance T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Sleep Disturbance domain. The change from baseline in PROMIS Sleep Disturbance Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Social Role Satisfaction T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score better functioning for the Social Role Satisfaction domain. The change from baseline in PROMIS Social Role Satisfaction Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Interference T-Score will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents worse symptomology for the Pain Interference domain. The change from baseline in PROMIS Pain Interference Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Pain Intensity will be used to assess trends over time in this health measure. The Pain Intensity on the PROMIS is a single item numerical rating scale where the respondent selects a whole number representing the average pain of the past 7 days ranging from 0 (no pain) to 10 (worst pain imaginable). The change from baseline in PROMIS Pain Intensity Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 1 (Baseline, Day 1), Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85 - Last Day of Treatment)

Measure

MEAN · T-Score

Reporting status

POSTED

The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank version 2.0 - Cognitive Function scale will be used to assess trends over time in this health measure. The raw score is calculated for and translated into a T-score per the PROMIS scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher score represents better cognitive function. The change from baseline in PROMIS Cognitive Function Score at Visit 3 (Day 29), Visit 4 (Day 57), and Visit 5 (Day 85) will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 5 (Day 85 - Last Day of Treatment)

Measure

NUMBER · Percentage of Participants

Reporting status

POSTED

At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of participants who responded that they received clinical benefit from the experimental drug treatment at the end of treatment will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Visit 5 (Day 85 - Last Day of Treatment)

Measure

NUMBER · Percentage of Physicians

Reporting status

POSTED

At the end of treatment, the participant and their physician will complete separately a survey asking what treatment assignment they believe they received (e.g., JBT-101, placebo, or cannot tell), whether the participant received benefit from their assigned treatment and whether the participant or their physician would choose the treatment received. The percentage of physicians who responded that the participant received clinical benefit from the experimental drug treatment at the end of treatment will be assessed.

Population: mITT - The number analyzed is mITT with available data at each visit. Due to dropout or missing scores, not everyone in mITT has data to contribute at each visit

Time frame

Day 1 after initiation of study intervention through Day 113

Measure

NUMBER · Number of Events

Reporting status

POSTED

Treatment-emergent Adverse Events grading will be defined by the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. The number of TEAE will be identified by monitoring participant-reported AEs, vital signs, medical history, physical exams, blood and urine safety tests, 12-lead electrocardiograms, and the Addiction Research Center Inventory-Marijuana (ARCI-M). TEAE are defined as AEs that, in the opinion of the blinded/masked site investigator, are " possibly", "probably" or "definitely" related to the assigned study treatment.

Population: The safety population includes all participants who received at least one dose of study treatment.

Time frame

Visit 1 (Baseline, Day 1) and Visit 5 (Day 85 - Last Day of Treatment)

Measure

NUMBER · Number of Events

Reporting status

POSTED

The number of treatment emergent QTc prolongation events will be identified when QTc prolongation \> 500 msec total duration and when the change from Visit 1 (Day 1) QTc interval prior to study drug administration \> 60 msec Twelve-lead ECGs were recorded in triplicate at Screening and Visits 1 (Day 1) and 5 (Day 85). The ECGs were evaluated for medically significant abnormalities and QT/QTc intervals. The QT/QTc intervals were measured at Visit 1 (Day 1) before administration and between 2.5 and 3.5 hours after administration of study product in the clinic, at the time of maximum JBT-101 concentration in the blood.

Population: The safety population includes all participants who received at least one dose of study treatment.

Time frame

Visit 3 (Day 29)

Measure

NUMBER · Number of Participants

Reporting status

POSTED

The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Visit 4 (Day 57)

Measure

NUMBER · participants

Reporting status

POSTED

The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Visit 5 (Day 85)

Measure

NUMBER · participants

Reporting status

POSTED

The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Visit 6 (Day 113)

Measure

NUMBER · participants

Reporting status

POSTED

The number of mild/moderate and severe disease flares will be assessed using the SFI instrument to define disease flare(s) and severity. The SELENA SLEDAI Flare Index categorizes disease flares as mild/moderate or severe, based on the highest categories of clinical features recorded or by treatment recommendations by the physician.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Visit 3 (Day 29)

Measure

NUMBER · Number of Participants

Reporting status

POSTED

The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Visit 4 (Day 57)

Measure

NUMBER · Number of Participants

Reporting status

POSTED

The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Visit 5 (Day 85)

Measure

NUMBER · Number of Participants

Reporting status

POSTED

The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Visit 6 (Day 113)

Measure

NUMBER · Number of Participants

Reporting status

POSTED

The number of BILAG-2004 disease flares as defined as one new BILAG A or two new BILAG B scores will be assessed. The BILAG-2004\* is a validated index for assessing SLE disease activity. The BILAG-2004 includes 97 clinical and laboratory items to evaluate SLE disease activity in 9 organ systems. \* BILAG-2004: British Isles Lupus Assessment Group 2004.

Population: The safety population includes all participants who received at least one dose of study treatment. Number of participants analyzed is number of participants in the safety population with data at the visit.

Time frame

Day 1 through Visit 6 (Day 113)

Measure

NUMBER · Number of Events

Reporting status

POSTED

The number of participants with elevated liver tests, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x upper limit of normal and total bilirubin \> 1.5 x the upper limit of normal, present on repeat testing, at Visit 3 (Day 29), Visit 4 (Day 57), Visit 5 (Day 85) and Visit 6 (Day 113) will be assessed.

Population: The safety population includes all participants who received at least one dose of study treatment.

Time frame

Day 1 after initiation of study intervention through Visit 5 (Day 85 - Last Day of Treatment)

Measure

NUMBER · Number of Events

Reporting status

POSTED

The number of intolerability events of the study drug, defined as incidence of discontinuation of study product due to TEAEs at least possibly related to study product from Visits 1 (Day 1) through 5 (Day 85) will be assessed.

Population: The safety population includes all participants who received at least one dose of study treatment.

Time frame

Visit 1 (Baseline, Day 1-prior to treatment initiation), Visit 1 (Baseline, Day 1-post-treatment initiation) Visit 3 (Day 29) and Visit 5 (Day 85 - Last Day of Treatment)

Measure

NUMBER · Percentage of Participants

Reporting status

POSTED

The percentage of participants who experienced ≥1 score increase on the ARCI-M from the Visit 1 (Day 1) pre-dose assessment at Visit 1 (Day 1) post-dose, Visit 3 (Day 29) and Visit 5 (Day 85) will be assessed. The ARCI-M questionnaire was completed by subjects at Visit1 (Day 1) pre- and post-dosing, Visit 3 (Day 29) and Visit 5 (Day 85). This is a 12-item true/false questionnaire developed by the National Institutes of Drug Abuse, designed to detect the full range of subjective responses experienced by marijuana users. An answer of true has an assigned value of 1 and an answer of false has an assigned value of 0. The ARCI-M score was computed as the sum of the assigned values for all 12 questions and can range from 0 to 12. If a question is missed, the score is not calculated.

Population: mITT