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

Primary Purpose

Diffuse Cutaneous Systemic Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenabasum 5 mg
Lenabasum 20 mg
Placebo oral capsule
Sponsored by
Corbus Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Cutaneous Systemic Sclerosis focused on measuring Scleroderma, cannabinoid receptor type 2 agonist, anabasum, JBT-101, lenabasum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California San Diego
  • Pacific Arthritis Care Center
  • UCLA
  • Stanford University
  • University of Colorado Anschutz Medical Campus
  • Georgetown University Medical Center
  • Northwestern University
  • Tulane University Medical Center
  • John Hopkins University, Scleroderma Center
  • Massachusetts General Hospital, Division of Rheumatology
  • Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)
  • Michigan Medicine
  • University of Minnesota Health Clinical Research Unit
  • Dartmouth Hitchcock Medical Center
  • Rutgers Clinical Research Center, Robert Wood Johnson Medical School
  • The Steffens Scleroderma at The Center for Rheumatology
  • Columbia University Medical Center
  • Hospital for Special Surgery
  • Cleveland Clinic
  • University of Toledo
  • University of Pennsylvania Health System - PCAM, Dept. of Rheumatology
  • UPMC Arthritis and Autoimmunity Center, Falk Clinic
  • Medical University of South Carolina
  • Metroplex Clinical Research Center
  • UTP Rheumatology Clinic
  • University of Utah Hospitals and Clinics
  • Medical College of Wisconsin/Froedtert Hospital
  • Royal Adelaide Hospital
  • Liverpool Hospital
  • St Vincent's Hospital
  • Royal Prince Alfred Hospital
  • Sir Mortimer B. Davis Jewish General Hospital
  • The Arthritis Centre
  • Universitätsklinikum Heidelberg
  • Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien-
  • University Hospital Cologne, Department of Dermatology and Venereology
  • Department of Internal Medicine 3, University of Erlangen-Nuremberg
  • University Medical Center Freiburg
  • Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie
  • Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz
  • University Hospital Ulm
  • Rambam Health Corporation
  • Bnai Zion Medical Center
  • Meir Medical Center - Internal Medicine E
  • Sheba Medical Center
  • Kyushu University Hospital
  • Kanazawa University Hospital
  • Gunma University Hospital
  • Hokkaido University Hospital
  • National University Corporation Tohoku University Tohoku University Hospital
  • Osaka University Hospital
  • Nippon Medical School Hospital
  • Yokohama City University Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Hanyang University Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Leiden University Medical Center
  • Erasmus Medical Center
  • Haga Hospital
  • Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie
  • Medyczne Centrum Hetmanska
  • Reum-Medica S.C
  • Hospital Universitari de la Santa Creu i Sant Pau
  • Hospital Universitario Doctor Peset
  • Cantonal Hospital St. Gallen
  • University Hospital Zurich
  • Ninewells Hospital
  • Freeman Hospital
  • Russell's Hall Hospital
  • Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)
  • Royal Free Hospital London NHS Foundation Trust
  • Guy's and St.Thomas' NHS Foundation Trust
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Lenabasum 5 mg BID

Lenabasum 20 mg BID

Placebo BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2018
Last Updated
March 25, 2021
Sponsor
Corbus Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03398837
Brief Title
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Acronym
RESOLVE-1
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated open-label extension
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corbus Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Cutaneous Systemic Sclerosis
Keywords
Scleroderma, cannabinoid receptor type 2 agonist, anabasum, JBT-101, lenabasum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Lenabasum 5 mg BID
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Lenabasum 20 mg BID
Arm Title
Cohort 3
Arm Type
Placebo Comparator
Arm Description
Placebo BID
Intervention Type
Drug
Intervention Name(s)
Lenabasum 5 mg
Intervention Description
Subjects will receive lenabasum 5 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Lenabasum 20 mg
Intervention Description
Subjects will receive lenabasum 20 mg twice daily.
Intervention Type
Other
Intervention Name(s)
Placebo oral capsule
Intervention Description
Subjects will receive placebo twice daily.
Primary Outcome Measure Information:
Title
Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.
Description
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.
Time Frame
American College of Rheumatology Combined Response Index score through study completion, up to 1 year.
Secondary Outcome Measure Information:
Title
Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.
Description
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.
Time Frame
Change from baseline through study completion, up to 1 year.
Title
Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.
Description
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.
Time Frame
Change from baseline through study completion, up to 1 year.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: ≥ 18 years of age at the time Informed Consent is signed. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk). Disease duration ≤ 6 years from the first non-Raynaud's symptom. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening. Key Exclusion Criteria: Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1. Any of the following values for laboratory tests at Screening: A positive pregnancy test in women of childbearing potential; Hemoglobin < 9 g/dL for males and < 8 g/dL for females; Neutrophils < 1.0 ×10^9/L; Platelets < 75 ×10^9/L; Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation; Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Spiera, MD
Organizational Affiliation
Professor of Clinical Medicine, Weill Cornell Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Denton, MD
Organizational Affiliation
Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pacific Arthritis Care Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
John Hopkins University, Scleroderma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Massachusetts General Hospital, Division of Rheumatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota Health Clinical Research Unit
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Rutgers Clinical Research Center, Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
The Steffens Scleroderma at The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
University of Pennsylvania Health System - PCAM, Dept. of Rheumatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Arthritis and Autoimmunity Center, Falk Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
UTP Rheumatology Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
Country
Australia
Facility Name
St Vincent's Hospital
City
Melbourne
ZIP/Postal Code
3065
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Sydney
Country
Australia
Facility Name
Sir Mortimer B. Davis Jewish General Hospital
City
Montréal
Country
Canada
Facility Name
The Arthritis Centre
City
Winnipeg
Country
Canada
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien-
City
Berlin
Country
Germany
Facility Name
University Hospital Cologne, Department of Dermatology and Venereology
City
Cologne
Country
Germany
Facility Name
Department of Internal Medicine 3, University of Erlangen-Nuremberg
City
Erlangen
Country
Germany
Facility Name
University Medical Center Freiburg
City
Freiburg
Country
Germany
Facility Name
Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie
City
Köln
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz
City
Nauheim
Country
Germany
Facility Name
University Hospital Ulm
City
Ulm
Country
Germany
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Facility Name
Meir Medical Center - Internal Medicine E
City
Kefar Saba
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
Country
Japan
Facility Name
National University Corporation Tohoku University Tohoku University Hospital
City
Sendai
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
South Holland
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Haga Hospital
City
The Hague
Country
Netherlands
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie
City
Lublin
Country
Poland
Facility Name
Medyczne Centrum Hetmanska
City
Poznań
Country
Poland
Facility Name
Reum-Medica S.C
City
Wrocław
Country
Poland
Facility Name
Hospital Universitari de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
Country
Spain
Facility Name
Cantonal Hospital St. Gallen
City
Saint Gallen
Country
Switzerland
Facility Name
University Hospital Zurich
City
Zürich
Country
Switzerland
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Russell's Hall Hospital
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)
City
Leeds
Country
United Kingdom
Facility Name
Royal Free Hospital London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St.Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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