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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03398837




Registration number
NCT03398837
Ethics application status
Date submitted
5/01/2018
Date registered
16/01/2018
Date last updated
13/01/2020

Titles & IDs
Public title
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Secondary ID [1] 0 0
JBT101-SSc-002
Universal Trial Number (UTN)
Trial acronym
RESOLVE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Cutaneous Systemic Sclerosis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenabasum 5 mg
Treatment: Drugs - Lenabasum 20 mg
Other interventions - Placebo oral capsule

Experimental: Cohort 1 - Lenabasum 5 mg BID

Experimental: Cohort 2 - Lenabasum 20 mg BID

Placebo Comparator: Cohort 3 - Placebo BID


Treatment: Drugs: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.

Treatment: Drugs: Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.

Other interventions: Placebo oral capsule
Subjects will receive placebo twice daily.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
American College of Rheumatology Combined Response Index score through study completion, up to 1 year.
Secondary outcome [1] 0 0
Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score. - 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.
Timepoint [1] 0 0
Change from baseline through study completion, up to 1 year.
Secondary outcome [2] 0 0
Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index. - 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.
Timepoint [2] 0 0
Change from baseline through study completion, up to 1 year.
Secondary outcome [3] 0 0
Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.
Timepoint [3] 0 0
Change from baseline through study completion, up to 1 year.

Eligibility
Key inclusion criteria
Key

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.

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
3065 - Melbourne
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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District of Columbia
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Illinois
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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New Hampshire
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New Jersey
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New York
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Ohio
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Pennsylvania
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South Carolina
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Texas
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Utah
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Wisconsin
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Canada
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Montréal
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Canada
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Winnipeg
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Germany
State/province [21] 0 0
Baden-Württemberg
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Germany
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Berlin
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Germany
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Cologne
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
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Köln
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Germany
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Nauheim
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Germany
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Ulm
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Israel
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Haifa
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Israel
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Kefar Saba
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Israel
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Ramat Gan
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Japan
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Fukuoka
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Japan
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Kanazawa
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Japan
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Maebashi
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Sapporo
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Sendai
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Suita
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Japan
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Tokyo
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Japan
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Yokohama
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Korea, Republic of
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Seoul
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Netherlands
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South Holland
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Rotterdam
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Netherlands
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The Hague
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Poland
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Lublin
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Poznan
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Wroclaw
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Barcelona
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Valencia
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Zürich
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Tyne And Wear
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West Midlands
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Leeds
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London
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United Kingdom
State/province [56] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Corbus Pharmaceuticals Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03398837
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Spiera, MD
Address 0 0
Professor of Clinical Medicine, Weill Cornell Medical College
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications