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Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis (RESOLVE-1)

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ClinicalTrials.gov Identifier: NCT03398837
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Diffuse Cutaneous Systemic Sclerosis Drug: Lenabasum 5 mg Drug: Lenabasum 20 mg Other: Placebo oral capsule Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Cohort 1
Lenabasum 5 mg BID
Drug: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.

Experimental: Cohort 2
Lenabasum 20 mg BID
Drug: Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.

Placebo Comparator: Cohort 3
Placebo BID
Other: Placebo oral capsule
Subjects will receive placebo twice daily.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 ARC 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.

  3. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398837


Contacts
Contact: Lindsey Smith 1-617-963-0707 SScPatients@corbuspharma.com
Contact: Barbara White, MD 1-617-977-5077 SScPhysicians@corbuspharma.com

  Hide Study Locations
Locations
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Si Yin Chin    858-246-2387    syc108@AD.UCSD.EDU   
Principal Investigator: Arthur Kavanaugh, MD         
Pacific Arthritis Care Center Recruiting
Los Angeles, California, United States, 90045
Contact: Omar Aly         
Principal Investigator: Daniel E Furst, MD         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Nashla Barroso    310-825-9682    NBarroso@mednet.ucla.edu   
Principal Investigator: Suzanne Kafaja, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Joel Nicholus         
Principal Investigator: Lorinda Chung, MD         
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Mallory Crow Adams    303-724-8403      
Principal Investigator: Aryeh Fischer, MD         
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Sabrina Elliott    202-444-6210    se510@georgetown.edu   
Principal Investigator: Virginia Steen, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary Carns    312-503-1137    m-carns@northwestern.edu   
Principal Investigator: John Varga, MD         
United States, Louisiana
Tulane University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Sandy Ditta    504-988-4040    sditta@tulane.edu   
Principal Investigator: Lesley Saketkoo, MD, MPH         
United States, Maryland
John Hopkins University, Scleroderma Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Gwendolyn Leatherman         
Principal Investigator: Laura Hummers, MD         
United States, Massachusetts
Massachusetts General Hospital, Division of Rheumatology Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kaitlin Schalago    617-726-2000    KSCHALAGO@mgh.harvard.edu   
Principal Investigator: Flavia V Castelino, MD         
Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU) Recruiting
Boston, Massachusetts, United States, 02118
Contact: Eric Stratton         
Principal Investigator: Robert Simms, MD         
United States, Michigan
Michigan Medicine Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Monica Sanborn    734-232-2090    monsan@med.umich.edu   
Principal Investigator: Vivek Nagaraja, MD         
United States, Minnesota
University of Minnesota Health Clinical Research Unit Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Julie Scherber, RN    612-626-8658      
Principal Investigator: Jerry Molitor, MD, PhD         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Ashley E Ladd    603-650-8587    Ashley.E.Ladd@hitchcock.org   
Principal Investigator: Nicole M Orzechowski, DO         
United States, New Jersey
Rutgers Clinical Research Center, Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Fei Chen, RN         
Principal Investigator: Vivien M Hsu, MD         
United States, New York
The Steffens Scleroderma at The Center for Rheumatology Active, not recruiting
Albany, New York, United States, 12203
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Rachel Broderick, MS    212-342-2713    rb3173@cumc.columbia.edu   
Principal Investigator: Elana J Bernstein, MD, MSc         
Hospital for Special Surgery Recruiting
New York, New York, United States, 10065
Contact: Anna Yusov         
Principal Investigator: Robert Spiera, MD         
Principal Investigator: Jessica Gordon, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Sonya Crook, RN    216-444-3290    crooks@ccf.org   
Principal Investigator: Soumya Chatterjee, RN         
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Jenny Gilmore, RN    419-383-6761      
Principal Investigator: Bashar Kahaleh, MD         
United States, Pennsylvania
University of Pennsylvania Health System - PCAM, Dept. of Rheumatology Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robin Neubauer         
Principal Investigator: Nora Sandorfi, MD         
UPMC Arthritis and Autoimmunity Center, Falk Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Dana Ivanco         
Principal Investigator: Robyn T Domsic, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Trevor Faith         
Contact    843-792-8997    faitht@musc.edu   
Principal Investigator: Edwin Smith, MD         
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Site Recruitment    214-424-0405    info@mcrcdallas.com   
Principal Investigator: Zoran Kurepa, MD, PhD         
UTP Rheumatology Clinic Recruiting
Houston, Texas, United States, 77030
Contact: Patricia Gonzales    713-500-7118    Patricia.Gonzales@uth.tmc.edu   
Principal Investigator: Maureen Mayes, MD         
United States, Utah
University of Utah Hospitals and Clinics Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jennifer Godina    801-581-4993      
Principal Investigator: Tracy Frech, MD         
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Amy Blair    414-955-7007    ablair@mcw.edu   
Principal Investigator: Mary Ellen Csuka, MD         
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia, 5000
Contact: Cindy Hall    + 61 8 7074 4068      
Principal Investigator: Susanna Proudman, MD         
Liverpool Hospital Recruiting
Liverpool, Australia
Contact: Fiona Briggs    + 61 2 8738 4088    Fiona.Briggs@health.nsw.gov.au   
Principal Investigator: Vivek Thakkar, MD         
St Vincent's Hospital Recruiting
Melbourne, Australia, 3065
Contact: Barbara Gemmel    + 61 3 9231 3983      
Principal Investigator: Wendy Stevens, MD         
Royal Prince Alfred Hospital Recruiting
Sydney, Australia
Contact: Study Coordinator    +61 2 95155874      
Principal Investigator: Peter Youssef, MD         
Canada
Sir Mortimer B. Davis Jewish General Hospital Recruiting
Montréal, Canada
Contact: Murray Baron, MD    514-340-8231      
Principal Investigator: Murray Baron, MD         
The Arthritis Centre Recruiting
Winnipeg, Canada
Contact: Arthritis Centre Research Coordinators    1-204-787-1969      
Principal Investigator: David Robinson, MD         
Germany
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Norbert Blank, MD    0049 6221 568030    Norbert.Blank@med.uni-heidelberg.de   
Principal Investigator: Norbert Blank, MD         
University Medical Center Freiburg Recruiting
Freiburg, Germany
Contact: Stephanie Finzel, MD    +49 761 270-74490    Stephanie.Finzel@uniklinik-freiburg.de   
Principal Investigator: Stephanie Finzel, MD         
University Hospital Ulm Recruiting
Ulm, Germany
Contact: Christiane Pfeiffer, MD    +49(0)731/500-57675    Christiane.Pfeiffer@uniklinik-ulm.de   
Principal Investigator: Christiane Pfeiffer, MD         
Israel
Rambam Health Corporation Recruiting
Haifa, Israel, 3109601
Contact: Vika Shataylo    972-(0)4-7771369      
Principal Investigator: Alexandra Balbir-Gurman, MD         
Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Tami Uzi    04-8359344    tami.uzi@b-zion.org.il   
Principal Investigator: Itzhak Rosner, MD         
Meir Medical Center - Internal Medicine E Recruiting
Kefar Saba, Israel
Contact: Eran Levi    972-9-7471936    eran.levi@clalit.org.il   
Principal Investigator: Yair Levy, MD         
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Tehila Befler    972-3-5304413    tehila.biton@sheba.health.gov.il   
Principal Investigator: Merav Lidar, MD         
Japan
Kyushu University Hospital Recruiting
Fukuoka, Japan
Kanazawa University Hospital Recruiting
Kanazawa, Japan
Gunma University Hospital Recruiting
Maebashi, Japan
Hokkaido University Hospital Recruiting
Sapporo, Japan
National University Corporation Tohoku University Tohoku University Hospital Recruiting
Sendai, Japan
Osaka University Hospital Recruiting
Suita, Japan
Nippon Medical School Hospital Recruiting
Tokyo, Japan
Yokohama City University Hospital Recruiting
Yokohama, Japan
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Eun Bong Lee, MD, PhD    81-10-3750-8918      
Principal Investigator: Eun Bong Lee, MD, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Chang Keun Lee, MD, PhD    82-2-3010-3284    cklee@amc.seoul.kr   
Principal Investigator: Chang Keun Lee, MD, PhD         
Hanyang University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jae-Bum Jun, MD, PhD    +82-2-2290-9244    junjb@hanyang.ac.kr   
Principal Investigator: Jae-Bum Jun, MD, PhD         
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ji Hyeon Ju, Professor    82-2-2258-6893    juji@catholic.ac.kr   
Principal Investigator: Ji Hyeon Ju, Professor         
Netherlands
Leiden University Medical Center Recruiting
Leiden, South Holland, Netherlands
Contact: Jeska Kirsten de Vries-Bouwstra, MD, PhD         
Contact    0031 715263598      
Principal Investigator: Jeska Kirsten de Vries-Bouwstra, MD, Phd         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: A.H.M. Ammerlaan    +31 6 341 000 73    a.ammerlaan@erasmusmc.nl   
Principal Investigator: V.A.S.H. Dalm, MD, PhD         
Haga Hospital Recruiting
The Hague, Netherlands
Contact: Yorik Visser    + 31 (0)70 210 2143    y.visser@hagaziekenhuis.nl   
Principal Investigator: Anne A Schouffoer, MD, PhD         
Spain
Hospital Universitari de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Secretary Phone    +34935565609      
Principal Investigator: Ivan Castellvi Barranco, MD, PhD         
Hospital Universitario Doctor Peset Recruiting
Valencia, Spain
Contact: Juan Jose Alegre Sancho, MD    +34 962 780 080    alegre_juasan@gva.es   
Principal Investigator: Juan Jose Alegre Sancho, MD         
Switzerland
Cantonal Hospital St. Gallen Recruiting
Saint Gallen, Switzerland
Contact: Andrea Rubbert-Roth, MD    0041 (0)71 494 11 11    andrea.rubbert-roth@kssg.ch   
Principal Investigator: Andrea Rubbert-Roth, MD         
University Hospital Zurich Recruiting
Zürich, Switzerland
Contact: Bahar Aydogan    044 255 29 70    oliver.distler@usz.ch   
Principal Investigator: Oliver Distler, MD         
United Kingdom
Ninewells Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Colin Baines, MBChB, MRCP    44-1382632287    colin.baines@nhs.net   
Principal Investigator: Colin Baines, MBChB, MRCP         
Freeman Hospital Recruiting
Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
Contact: Rheumatology Research Team    +44 (0) 191 2137751      
Principal Investigator: Bridget Griffiths, MD         
Russell's Hall Hospital Recruiting
Dudley, West Midlands, United Kingdom, DY1 2HQ
Contact: Karen Douglas, MD    +44 (0)1384 456111 ext 5803    karendouglas@nhs.net   
Principal Investigator: Karen Douglas, MD         
Royal Free Hospital London NHS Foundation Trust Recruiting
London, United Kingdom, NW3 2QG
Contact: Site Recruitment       rf.clinicaltrials@nhs.net   
Principal Investigator: Christopher C Denton, PhD, FRCP         
Guy's and St.Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Contact: David D'Cruz, MD    +44 (0)207188 9756    david.d'cruz@kcl.ac.uk   
Principal Investigator: David D'Cruz, MD         
Salford Royal NHS Foundation Trust Recruiting
Salford, United Kingdom, M6 8HD
Contact: Ariane Herrick, MD    0161-206-0534    rheumatology.research@nhs.net   
Principal Investigator: Ariane Herrick, MD         
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Investigators
Principal Investigator: 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

Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03398837     History of Changes
Other Study ID Numbers: JBT101-SSc-002
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corbus Pharmaceuticals Inc.:
Scleroderma
cannabinoid receptor type 2 agonist
anabasum
JBT-101
lenabasum

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases