Trials Sponsors Conditions Drugs Pricing

Conditions

Diffuse Cutaneous Systemic Sclerosis

Keywords

Sclerodermacannabinoid receptor type 2 agonistanabasumJBT-101lenabasum

Outcome Measures

Primary Outcomes (1)

Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.
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.
American College of Rheumatology Combined Response Index score through study completion, up to 1 year.

Secondary Outcomes (3)

Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.
Change from baseline through study completion, up to 1 year.
Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.
Change from baseline through study completion, up to 1 year.
Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.
Change from baseline through study completion, up to 1 year.

Study Arms (3)

Cohort 1

EXPERIMENTAL

Lenabasum 5 mg BID

Drug: Lenabasum 5 mg

Cohort 2

EXPERIMENTAL

Lenabasum 20 mg BID

Drug: Lenabasum 20 mg

Cohort 3

PLACEBO COMPARATOR

Placebo BID

Other: Placebo oral capsule

Interventions

Lenabasum 5 mgDrug

Subjects will receive lenabasum 5 mg twice daily.

Cohort 1

Lenabasum 20 mgDrug

Subjects will receive lenabasum 20 mg twice daily.

Cohort 2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥ 18 years of age at the time Informed Consent is signed.
Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).

Sponsors & Collaborators

Corbus Pharmaceuticals Inc.
Industrylead

Study Sites (74)

University of California San Diego

La Jolla, California, 92037, United States

Pacific Arthritis Care Center

Los Angeles, California, 90045, United States

UCLA

Los Angeles, California, 90095, United States

Stanford University

Palo Alto, California, 94304, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Northwestern University

Chicago, Illinois, 60611, United States

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

lenabasum

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

Robert Spiera, MD
Professor of Clinical Medicine, Weill Cornell Medical College
PRINCIPAL INVESTIGATOR
Chris Denton, MD
Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital
PRINCIPAL INVESTIGATOR

Enrollment

365 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 16, 2018

Study Start

December 18, 2017

Actual (reported)

Study Stopped

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Cohort 1

Cohort 2

Cohort 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (74)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Cohort 1

Cohort 2

Cohort 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (74)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations