Clinical trial NCT03398837: Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diffuse Cutaneous Systemic Sclerosis
Keywords: Scleroderma
cannabinoid receptor type 2 agonist
anabasum
JBT-101
lenabasum
Lead sponsor: Corbus Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-16
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.
timeFrame: American College of Rheumatology Combined Response Index score through study completion, up to 1 year.
Secondary outcomes:
measure: Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.
timeFrame: Change from baseline through study completion, up to 1 year.
measure: Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.
timeFrame: Change from baseline through study completion, up to 1 year.
measure: Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.
timeFrame: Change from baseline through study completion, up to 1 year.
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: Pacific Arthritis Care Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins University, Scleroderma Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, Division of Rheumatology
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center (BUMC) - General Clinical Research Unit (GCRU)
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Health Clinical Research Unit
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers Clinical Research Center, Robert Wood Johnson Medical School
state: New Jersey
city: Albany
country: United States
facility: The Steffens Scleroderma at The Center for Rheumatology
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System - PCAM, Dept. of Rheumatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Arthritis and Autoimmunity Center, Falk Clinic
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: UTP Rheumatology Clinic
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/Froedtert Hospital
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Melbourne
country: Australia
facility: St Vincent's Hospital
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Montréal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
city: Winnipeg
country: Canada
facility: The Arthritis Centre
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Berlin
country: Germany
facility: Charité- Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie, Abteilung -Neue Therapien & Studien-
city: Cologne
country: Germany
facility: University Hospital Cologne, Department of Dermatology and Venereology
city: Erlangen
country: Germany
facility: Department of Internal Medicine 3, University of Erlangen-Nuremberg
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Köln
country: Germany
facility: Universitätsklinik Köln,Klinik und Poliklinik für Dermatologie und Venerologie
city: Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH, Zentrum Rheumatologie u. Klin. Immunologie, Studienambulanz
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Haifa
country: Israel
facility: Rambam Health Corporation
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Kefar Saba
country: Israel
facility: Meir Medical Center - Internal Medicine E
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Maebashi
country: Japan
facility: Gunma University Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sendai
country: Japan
facility: National University Corporation Tohoku University Tohoku University Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: The Hague
country: Netherlands
facility: Haga Hospital
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1; Katedra i Klinika Dermatologii, Wenerologii i Dermatologii Dziecięcej Uniwersytetu Medycznego w Lublinie
city: Poznań
country: Poland
facility: Medyczne Centrum Hetmanska
city: Wrocław
country: Poland
facility: Reum-Medica S.C
city: Barcelona
country: Spain
facility: Hospital Universitari de la Santa Creu i Sant Pau
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Saint Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
city: Zürich
country: Switzerland
facility: University Hospital Zurich
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Scotland
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
state: Tyne And Wear
city: Dudley
country: United Kingdom
facility: Russell's Hall Hospital
state: West Midlands
city: Leeds
country: United Kingdom
facility: Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM)
city: London
country: United Kingdom
facility: Royal Free Hospital London NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St.Thomas' NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: Professor of Clinical Medicine, Weill Cornell Medical College
name: Robert Spiera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Experimental Rheumatology and Consultant Rheumatologist and Centre Head, Royal Free Hospital
name: Chris Denton, MD
role: PRINCIPAL_INVESTIGATOR
References: