INTERVENTIONALTERMINATEDNCT03398837

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2021-03-29

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 365 (ACTUAL)
Start date: 2017-12-18
Sponsor: Corbus Pharmaceuticals Inc.
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 74
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Lenabasum

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Lenabasum 5 mg

Subjects will receive lenabasum 5 mg twice daily.

DRUG

Lenabasum 20 mg

Subjects will receive lenabasum 20 mg twice daily.

OTHER

Placebo oral capsule

Subjects will receive placebo twice daily.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Inclusion criteria

1. ≥ 18 years of age at the time Informed Consent is signed. 2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk). 3. Disease duration ≤ 6 years from the first non-Raynaud's symptom. 4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.

Exclusion criteria

1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1. 2. Any of the following values for laboratory tests at Screening: 1. A positive pregnancy test in women of childbearing potential; 2. Hemoglobin \< 9 g/dL for males and \< 8 g/dL for females; 3. Neutrophils \< 1.0 ×10\^9/L; 4. Platelets \< 75 ×10\^9/L; 5. Creatinine clearance \< 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation; 6. Aspartate aminotransferase or alanine aminotransferase \> 2.0 × upper limit of normal. 3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

primary outcomes

primary measures

Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.

Time frame: American College of Rheumatology Combined Response Index score through study completion, up to 1 year.

The ACR CRISS exponential algorithm determines the predicted probability of improvement from baseline, incorporating change in mRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A higher score indicates greater improvement.

secondary outcomes

secondary measures

Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.

Time frame: Change from baseline through study completion, up to 1 year.

mRSS evaluates a subject's skin thickness on a 4 point scale for 17 surface anatomic areas: 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch skin into fold. The individual values of the 17 surface areas are summed to define the total skin score with a maximum score of 51.

Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.

Time frame: Change from baseline through study completion, up to 1 year.

It includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The individual scores of the eight sections are summed and divided by 8. The result is the disability index or functional disability index. A higher score indicates more functional disability.

Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.

Time frame: Change from baseline through study completion, up to 1 year.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 43f69d3b-88ec-41d6-b8f6-9ec5664d01ae
Retrieved: 11/09/2026, 14:14:59
SHA-256: fb51928f6b1d05b30009f0fe00bd65851aef1346bbca5c32db59bd736cf7a7bc