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

Sponsor
Corbus Pharmaceuticals Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03398837
Collaborator
(none)
365
Enrollment
74
Locations
3
Arms
36.1
Actual Duration (Months)
4.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lenabasum 5 mg
  • Drug: Lenabasum 20 mg
  • Other: Placebo oral capsule
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
365 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 :
Dec 18, 2017
Actual Primary Completion Date :
May 27, 2020
Actual Study Completion Date :
Dec 21, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

  1. 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.]

    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.

  2. 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.]

    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.

  3. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  3. A positive pregnancy test in women of childbearing potential;

  4. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;

  5. Neutrophils < 1.0 ×10^9/L;

  6. Platelets < 75 ×10^9/L;

  7. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;

  8. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.

  9. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Diego La Jolla California United States 92037
2 Pacific Arthritis Care Center Los Angeles California United States 90045
3 UCLA Los Angeles California United States 90095
4 Stanford University Palo Alto California United States 94304
5 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045
6 Georgetown University Medical Center Washington District of Columbia United States 20007
7 Northwestern University Chicago Illinois United States 60611
8 Tulane University Medical Center New Orleans Louisiana United States 70112
9 John Hopkins University, Scleroderma Center Baltimore Maryland United States 21224
10 Massachusetts General Hospital, Division of Rheumatology Boston Massachusetts United States 02114
11 Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU) Boston Massachusetts United States 02118
12 Michigan Medicine Ann Arbor Michigan United States 48109
13 University of Minnesota Health Clinical Research Unit Minneapolis Minnesota United States 55455
14 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
15 Rutgers Clinical Research Center, Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901
16 The Steffens Scleroderma at The Center for Rheumatology Albany New York United States 12203
17 Columbia University Medical Center New York New York United States 10032
18 Hospital for Special Surgery New York New York United States 10065
19 Cleveland Clinic Cleveland Ohio United States 44195
20 University of Toledo Toledo Ohio United States 43614
21 University of Pennsylvania Health System - PCAM, Dept. of Rheumatology Philadelphia Pennsylvania United States 19104
22 UPMC Arthritis and Autoimmunity Center, Falk Clinic Pittsburgh Pennsylvania United States 15261
23 Medical University of South Carolina Charleston South Carolina United States 29425
24 Metroplex Clinical Research Center Dallas Texas United States 75231
25 UTP Rheumatology Clinic Houston Texas United States 77030
26 University of Utah Hospitals and Clinics Salt Lake City Utah United States 84132
27 Medical College of Wisconsin/Froedtert Hospital Milwaukee Wisconsin United States 53226
28 Royal Adelaide Hospital Adelaide Australia 5000
29 Liverpool Hospital Liverpool Australia
30 St Vincent's Hospital Melbourne Australia 3065
31 Royal Prince Alfred Hospital Sydney Australia
32 Sir Mortimer B. Davis Jewish General Hospital Montréal Canada
33 The Arthritis Centre Winnipeg Canada
34 Universitätsklinikum Heidelberg Heidelberg Baden-Württemberg Germany 69120
35 Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien- Berlin Germany
36 University Hospital Cologne, Department of Dermatology and Venereology Cologne Germany
37 Department of Internal Medicine 3, University of Erlangen-Nuremberg Erlangen Germany
38 University Medical Center Freiburg Freiburg Germany
39 Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie Köln Germany
40 Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz Nauheim Germany
41 University Hospital Ulm Ulm Germany
42 Rambam Health Corporation Haifa Israel 3109601
43 Bnai Zion Medical Center Haifa Israel
44 Meir Medical Center - Internal Medicine E Kefar Saba Israel
45 Sheba Medical Center Ramat Gan Israel
46 Kyushu University Hospital Fukuoka Japan
47 Kanazawa University Hospital Kanazawa Japan
48 Gunma University Hospital Maebashi Japan
49 Hokkaido University Hospital Sapporo Japan
50 National University Corporation Tohoku University Tohoku University Hospital Sendai Japan
51 Osaka University Hospital Suita Japan
52 Nippon Medical School Hospital Tokyo Japan
53 Yokohama City University Hospital Yokohama Japan
54 Seoul National University Hospital Seoul Korea, Republic of 03080
55 Asan Medical Center Seoul Korea, Republic of 05505
56 Hanyang University Medical Center Seoul Korea, Republic of
57 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of
58 Leiden University Medical Center Leiden South Holland Netherlands
59 Erasmus Medical Center Rotterdam Netherlands
60 Haga Hospital The Hague Netherlands
61 Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie Lublin Poland
62 Medyczne Centrum Hetmanska Poznań Poland
63 Reum-Medica S.C Wrocław Poland
64 Hospital Universitari de la Santa Creu i Sant Pau Barcelona Spain
65 Hospital Universitario Doctor Peset Valencia Spain
66 Cantonal Hospital St. Gallen Saint Gallen Switzerland
67 University Hospital Zurich Zürich Switzerland
68 Ninewells Hospital Dundee Scotland United Kingdom DD1 9SY
69 Freeman Hospital Newcastle Tyne And Wear United Kingdom NE7 7DN
70 Russell's Hall Hospital Dudley West Midlands United Kingdom DY1 2HQ
71 Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM) Leeds United Kingdom
72 Royal Free Hospital London NHS Foundation Trust London United Kingdom NW3 2QG
73 Guy's and St.Thomas' NHS Foundation Trust London United Kingdom
74 Salford Royal NHS Foundation Trust Salford United Kingdom M6 8HD

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT03398837
Other Study ID Numbers:
  • JBT101-SSc-002
First Posted:
Jan 16, 2018
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
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:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Dronabinol
Lenabasum

Study Results

No Results Posted as of Mar 29, 2021