Diffuse Cutaneous Systemic SclerosisPhase 3RESOLVE-1NCT03398837
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
A Phase 3 study testing Lenabasum 5 mg and Lenabasum 20 mg in people with Diffuse Cutaneous Systemic Sclerosis, run by Corbus Pharmaceuticals Inc. at 74 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Cutaneous Systemic Sclerosis
- What is being tested?
- Lenabasum 5 mg and Lenabasum 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 74 sitesin 12 countries
- Study dates
- 18 Dec 2017to 21 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
74 sites in 12 countries.
74 sites in 12 countries
United States27 sites
The Steffens Scleroderma at The Center for Rheumatology
Albany, New York, 12203
Michigan Medicine
Ann Arbor, Michigan, 48109
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
John Hopkins University, Scleroderma Center
Baltimore, Maryland, 21224
Massachusetts General Hospital, Division of Rheumatology
Boston, Massachusetts, 02114
Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Metroplex Clinical Research Center
Dallas, Texas, 75231
UTP Rheumatology Clinic
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92037
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Pacific Arthritis Care Center
Los Angeles, California, 90045
UCLA
Los Angeles, California, 90095
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota Health Clinical Research Unit
Minneapolis, Minnesota, 55455
Rutgers Clinical Research Center, Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Tulane University Medical Center
New Orleans, Louisiana, 70112
Columbia University Medical Center
New York, New York, 10032
Hospital for Special Surgery
New York, New York, 10065
Stanford University
Palo Alto, California, 94304
University of Pennsylvania Health System - PCAM, Dept. of Rheumatology
Philadelphia, Pennsylvania, 19104
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania, 15261
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
University of Toledo
Toledo, Ohio, 43614
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Germany8 sites
Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien-
Berlin
University Hospital Cologne, Department of Dermatology and Venereology
Cologne
Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie
Cologne
Department of Internal Medicine 3, University of Erlangen-Nuremberg
Erlangen
University Medical Center Freiburg
Freiburg im Breisgau
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz
Nauheim
University Hospital Ulm
Ulm
Japan8 sites
Kyushu University Hospital
Fukuoka
Kanazawa University Hospital
Kanazawa
Gunma University Hospital
Maebashi
Hokkaido University Hospital
Sapporo
National University Corporation Tohoku University Tohoku University Hospital
Sendai
Osaka University Hospital
Suita
Nippon Medical School Hospital
Tokyo
Yokohama City University Hospital
Yokohama
United Kingdom7 sites
Russell's Hall Hospital
Dudley, West Midlands, DY1 2HQ
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)
Leeds
Royal Free Hospital London NHS Foundation Trust
London, NW3 2QG
Guy's and St.Thomas' NHS Foundation Trust
London
Freeman Hospital
Newcastle, Tyne and Wear, NE7 7DN
Salford Royal NHS Foundation Trust
Salford, M6 8HD
Australia4 sites
Royal Adelaide Hospital
Adelaide, 5000
Liverpool Hospital
Liverpool
St Vincent's Hospital
Melbourne, 3065
Royal Prince Alfred Hospital
Sydney
Israel4 sites
Rambam Health Corporation
Haifa, 3109601
Bnai Zion Medical Center
Haifa
Meir Medical Center - Internal Medicine E
Kfar Saba
Sheba Medical Center
Ramat Gan
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Hanyang University Medical Center
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Netherlands3 sites
Leiden University Medical Center
Leiden, South Holland
Erasmus Medical Center
Rotterdam
Haga Hospital
The Hague
Poland3 sites
Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie
Lublin
Medyczne Centrum Hetmanska
Poznan
Reum-Medica S.C
Wroclaw
Canada2 sites
Sir Mortimer B. Davis Jewish General Hospital
Montreal
The Arthritis Centre
Winnipeg
Spain2 sites
Hospital Universitari de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Doctor Peset
Valencia
Switzerland2 sites
Cantonal Hospital St. Gallen
Sankt Gallen
University Hospital Zurich
Zurich
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
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.
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Being tested
- Lenabasum 5 mg, Lenabasum 20 mg, Placebo oral capsule
- Keywords
- Scleroderma, cannabinoid receptor type 2 agonist, anabasum, JBT-101, lenabasum
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenabasum 5 mgDrug
Subjects will receive lenabasum 5 mg twice daily.
Lenabasum 20 mgDrug
Subjects will receive lenabasum 20 mg twice daily.
Placebo oral capsuleOther
Subjects will receive placebo twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Lenabasum 5 mg BID Receives: Drug: Lenabasum 5 mg |
| Cohort 2 | Experimental | Lenabasum 20 mg BID Receives: Drug: Lenabasum 20 mg |
| Cohort 3 | Placebo comparator | Placebo BID Receives: Other: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Measured: Change from baseline through study completion, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start18 Dec 2017
- Primary completion27 May 2020
- Study completion21 Dec 2020
Why it stopped: Sponsor terminated open-label extension
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Cutaneous Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Spiera, MD, Principal investigator, Professor of Clinical Medicine, Weill Cornell Medical CollegeChris Denton, MD, Principal investigator, Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398837
- Sponsor's protocol ID
- JBT101-SSc-002
- Acronym
- RESOLVE-1
- Status last verified
- Mar 2021
- First submitted
- 5 Jan 2018
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03398837
- Acronym / sponsor ID
- RESOLVE-1 / JBT101-SSc-002
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Keywords
- Scleroderma, cannabinoid receptor type 2 agonist, anabasum, JBT-101, lenabasum
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated open-label extension
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Corbus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Lenabasum 5 mgLenabasum 5 mg BID |
| Cohort 2 | Experimental | Drug: Lenabasum 20 mgLenabasum 20 mg BID |
| Cohort 3 | Placebo comparator | Other: Placebo oral capsulePlacebo BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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 (9 listed)
- Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
- Any of the following values for laboratory tests at Screening:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenabasum 5 mgSubjects will receive lenabasum 5 mg twice daily. | Drug | Cohort 1 |
| Lenabasum 20 mgSubjects will receive lenabasum 20 mg twice daily. | Drug | Cohort 2 |
| Placebo oral capsuleSubjects will receive placebo twice daily. | Other | Cohort 3 |
Primary outcome
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 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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study was stopped early (reason given: Sponsor terminated open-label extension). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Spiera, MD principal investigator
Professor of Clinical Medicine, Weill Cornell Medical College
Chris Denton, MD principal investigator
Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital
74 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lenabasum 5 mg and Lenabasum 20 mg in people with Diffuse Cutaneous Systemic Sclerosis, run by Corbus Pharmaceuticals Inc. at 74 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Germany, Japan, United Kingdom, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor terminated open-label extension). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.