Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

Study Purpose

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of treatment with study drug is 52 weeks.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Fulfill one of the following criteria for dermatomyositis: 1.
Bohan and Peter criteria (Bohan and Peter, 1975a; Bohan and Peter 1975b) 2. ACR/EULAR criteria (Lundberg et al, 2017)
  • - Disease activity/severity fulfills one of the following three criteria: 1.
MDGA ≥ 3 cm (0
  • - 10 cm Visual Analog Scale [VAS]) and MMT-8 score ≤ 142 (out of 150 total possible) 2.
Sum of MDGA, PtGA and EMGA VAS scores is ≥ 10 cm (0-10 cm VAS for each) 3. MDGA ≥ 3 cm (0-10 cm VAS) and CDASI activity score of > 14
  • - Stable doses of immunosuppressive medications for DM as defined by: 1.
Unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before Visit 1 2. Unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before Screening

Exclusion Criteria:

  • - Unstable DM or DM with end-stage organ involvement at Screening or Visit 1 - Significant diseases or conditions other than DM that may influence response to the study drug or safety - Any of the following values for laboratory tests at Screening: 1.
A positive pregnancy test (or at Visit 1) 2. Hemoglobin < 9 g/dL in males and < 8 g/dL in females 3. Neutrophils < 1.0 × 10^9/L 4. Platelets < 75 × 10^9/L 5. Creatinine clearance < 50 mL/min on screening blood test, per the Modification of Diet in Renal Disease Study or in 24 hour urine creatine clearance measurement

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03813160
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Corbus Pharmaceuticals Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Victoria P Werth, MDChester V Oddis, MD
Principal Investigator Affiliation University of PennsylvaniaUniversity of Pittsburgh Department of Medicine/Division of Rheumatology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Spain, Sweden, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dermatomyositis
Additional Details

Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 52 will be Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.

Arms & Interventions

Arms

Experimental: Lenabasum 20 mg

Subjects will receive lenabasum 20 mg twice daily

Experimental: Lenabasum 5 mg

Subjects will receive lenabasum 5 mg twice daily

Placebo Comparator: Placebo

Subjects will receive placebo twice daily

Interventions

Drug: - Lenabasum 20 mg

oral capsule

Drug: - Lenabasum 5 mg

oral capsule

Drug: - Placebo

oral capsule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

HonorHealth Neurology, Phoenix, Arizona

Status

Recruiting

Address

HonorHealth Neurology

Phoenix, Arizona, 85018

Site Contact

Jennifer Pruitt

[email protected]

480-587-6147

Mayo Clinic, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic

Scottsdale, Arizona, 85259

Site Contact

Emily Branch

[email protected]

480-301-9392

Attune Health Center, Beverly Hills, California

Status

Recruiting

Address

Attune Health Center

Beverly Hills, California, 90211

Site Contact

Natalie Fortune

[email protected]

424-281-3653

University of California San Diego, La Jolla, California

Status

Recruiting

Address

University of California San Diego

La Jolla, California, 92037

Site Contact

Amina Arshad

[email protected]

858-246-2389

UCLA Division of Rheumatology, Los Angeles, California

Status

Recruiting

Address

UCLA Division of Rheumatology

Los Angeles, California, 90095

Site Contact

Jennifer Perez

[email protected]

310-794-2468

Denver Arthritis Clinic, Denver, Colorado

Status

Recruiting

Address

Denver Arthritis Clinic

Denver, Colorado, 80230

Site Contact

Theresa Hernandez

[email protected]

303-394-2828 #177

Yale University, New Haven, Connecticut

Status

Recruiting

Address

Yale University

New Haven, Connecticut, 06519

Site Contact

Agnieszka Zaleski

[email protected]

203-785-6631

Georgetown University, Washington, District of Columbia

Status

Recruiting

Address

Georgetown University

Washington, District of Columbia, 20001

Site Contact

Sabrina Elliott

[email protected]

202-444-6210

Mayo Clinic, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic

Jacksonville, Florida, 32224

Site Contact

Jany Paulett, CCRC

[email protected]

904-953-6912

University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Bethly Aubourg

[email protected]

305-243-8567

University of South Florida, Tampa, Florida

Status

Recruiting

Address

University of South Florida

Tampa, Florida, 33612

Site Contact

Gail Lewis, RN

[email protected]

813-974-9509

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Kathleen Aren

[email protected]

312-503-1824

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Samantha Colgan

[email protected]

913-945-9938

DelRicht Research, New Orleans, Louisiana

Status

Recruiting

Address

DelRicht Research

New Orleans, Louisiana, 70115

Site Contact

Josh Taylor

[email protected]

504-336-2667

Johns Hopkins Bayview Medical Center, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224

Site Contact

Grazyna Purwin

[email protected]

410-550-3609

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Stacey Anderson

[email protected]

734-998-1271

Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota, Division of Rheumatic and Autoimmune Diseases

Minneapolis, Minnesota, 55455

Site Contact

Mandi DeGrote

[email protected]

612-626-7609

Washington University in St. Louis, Saint Louis, Missouri

Status

Recruiting

Address

Washington University in St. Louis

Saint Louis, Missouri, 63110

Site Contact

Jennifer Bruns

[email protected]

314-747-5366

New York, New York

Status

Recruiting

Address

NYU School of Medicine; The Ronald O. Perelman Dept. of Dermatology

New York, New York, 10016

Site Contact

Susan Cataldo

[email protected]

212-263-5244

Hospital for Special Surgery, New York, New York

Status

Recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Site Contact

Liza Morales

[email protected]

212-774-2561

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Beverly Doyle

[email protected]

216-636-1196

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Josef Concha, MD

[email protected]

215-615-2940

Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh, Division of Rheumatology

Pittsburgh, Pennsylvania, 15261

Site Contact

Diane Koontz

[email protected]

412-383-8671

MUSC: Department of Neurology, Charleston, South Carolina

Status

Recruiting

Address

MUSC: Department of Neurology

Charleston, South Carolina, 29425

Site Contact

Aparna Choudhury

[email protected]

843-792-2845

Austin Neuromuscular Center, Austin, Texas

Status

Recruiting

Address

Austin Neuromuscular Center

Austin, Texas, 78756

Site Contact

Nawar Hussin

[email protected]

512-920-0140

Rheumatic Disease Center, Glendale, Wisconsin

Status

Recruiting

Address

Rheumatic Disease Center

Glendale, Wisconsin, 53217

Site Contact

Lynn Kritter

[email protected]

414-351-4009 #38

International Sites

Plovdiv, Bulgaria

Status

Recruiting

Address

University Hospital "Kaspela" Rheumatology Clinic

Plovdiv, ,

Site Contact

Anastas Batalov, MD, PhD

[email protected]

+359 32 602273

UMHAT "St. Ivan Rilski", Sofia, Bulgaria

Status

Recruiting

Address

UMHAT "St. Ivan Rilski"

Sofia, ,

Site Contact

Prof. Zlatimir Kolarov, MD

[email protected]

359888220118

UMHAT, Stara Zagora, Bulgaria

Status

Recruiting

Address

UMHAT

Stara Zagora, , 6000

Site Contact

Tanya Aleksieva-Petkova

[email protected]

00359898979821

Vancouver, British Columbia, Canada

Status

Recruiting

Address

University of British Columbia, Dept. of Dermatology and Skin Science

Vancouver, British Columbia, V5Z 4E8

Site Contact

Jaspal Mor

[email protected]

604-875-5296

Revmatologicky ustav, Prague, Czechia

Status

Recruiting

Address

Revmatologicky ustav

Prague, , 12850

Site Contact

Jiri Vencovsky, MD, DSc.

[email protected]

1-617-963-0707

Berlin, Germany

Status

Recruiting

Address

Charite-Universitatsmedizin, Division of Rheumatology and Clinical Immunology

Berlin, ,

Site Contact

Jan Zernicke

[email protected]

+4930450613025

Charite-Universitatsmedizin, Berlin, Germany

Status

Recruiting

Address

Charite-Universitatsmedizin

Berlin, ,

Site Contact

Margitta Worm, Prof

[email protected]

+4930450518105

University Hospital Erlangen Nuremberg, Erlangen, Germany

Status

Recruiting

Address

University Hospital Erlangen Nuremberg

Erlangen, , D- 91054

Site Contact

Jörg Distler, Prof

[email protected]

+49-9131-8543014

University Medical Center Goettingen, Göttingen, Germany

Status

Recruiting

Address

University Medical Center Goettingen

Göttingen, ,

Site Contact

Jens Schmidt, Prof

[email protected]n.de

+49-551-39-9293

University of Debrecen, Debrecen, Hungary

Status

Recruiting

Address

University of Debrecen

Debrecen, ,

Site Contact

Anett Vincze

[email protected]

36307178948

Pécs, Hungary

Status

Recruiting

Address

Department of Rheumatology and Immunology, Clinical Centre, University of Pecs

Pécs, ,

Site Contact

Cecilia Varju, MD, PhD

[email protected]

+36-72-536-802

Catania, Italy

Status

Recruiting

Address

University Hospital Policlinico-Vittorio Emanuele

Catania, , 95121

Site Contact

Rosario Foti

[email protected]

1-617-963-0707

Pisa, Italy

Status

Recruiting

Address

Pisa University Hospital - Santa Chiara Hospital, Reumatology Unit

Pisa, ,

Site Contact

Simone Barsotti

Sim[email protected]

+390502210625

Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario A.Gemelli-IRCCS

Roma, , 00168

Site Contact

Elisa Gremese

[email protected]

1-617-963-0707

Gunma University Hospital, Gunma, Japan

Status

Recruiting

Address

Gunma University Hospital

Gunma, ,

Hokkaido University Hospital, Hokkaido, Japan

Status

Recruiting

Address

Hokkaido University Hospital

Hokkaido, ,

Yokohama City University Hospital, Kanagawa, Japan

Status

Recruiting

Address

Yokohama City University Hospital

Kanagawa, ,

Kyoto University Hospital, Kyoto, Japan

Status

Recruiting

Address

Kyoto University Hospital

Kyoto, ,

Tohoku University Hospital, Miyagi, Japan

Status

Recruiting

Address

Tohoku University Hospital

Miyagi, ,

Nagasaki University Hospital, Nagasaki, Japan

Status

Recruiting

Address

Nagasaki University Hospital

Nagasaki, ,

Osaka University Hospital, Osaka, Japan

Status

Recruiting

Address

Osaka University Hospital

Osaka, ,

Keio University Hospital, Tokyo, Japan

Status

Recruiting

Address

Keio University Hospital

Tokyo, ,

Nippon Medical School Hospital, Tokyo, Japan

Status

Recruiting

Address

Nippon Medical School Hospital

Tokyo, ,

Wakayama Medical Hospital, Wakayama, Japan

Status

Recruiting

Address

Wakayama Medical Hospital

Wakayama, ,

Inha University Hospital, Incheon, Korea, Republic of

Status

Recruiting

Address

Inha University Hospital

Incheon, ,

Site Contact

YeRa Jo

[email protected]

1-617-963-0707

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Site Contact

Kim Jo Eun

[email protected]

1-617-963-0707

Hanyang University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Hanyang University Hospital

Seoul, ,

Site Contact

Hyun Jung Kim

[email protected]

1-617-963-0707

Seoul St. Mary's Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul St. Mary's Hospital

Seoul, ,

Site Contact

Chang Ae Moon

[email protected]

82-2-2258-2034

KLIMED, Bialystok, Poland

Status

Recruiting

Address

KLIMED

Bialystok, ,

Site Contact

Karolina Bagnowska

[email protected]l

+48 882 709 710

IRMED, Piotrków Trybunalski, Poland

Status

Recruiting

Address

IRMED

Piotrków Trybunalski, ,

Site Contact

Iwona Klimkiewicz

[email protected]

+48 605 908 809

Rzeszow, Poland

Status

Recruiting

Address

Kliniczny Szpital Wojewodzki Nr 1. im Fryderyka Chopina Klinika Dermatologii

Rzeszow, , 35-055

Site Contact

Adam Reich

[email protected]

1-617-963-0707

Warsaw, Poland

Status

Recruiting

Address

National Institute of Geriatrics, Rheumatology and Rehabilitation

Warsaw, , 02-637

Site Contact

Marzena Olesinska

[email protected]

1-617-963-0707

KLIMED, Łomża, Poland

Status

Recruiting

Address

KLIMED

Łomża, , 18-404

Site Contact

Marek Klimkiewicz

badan[email protected]

+48 603 157 778

Vall d'Hebron General Hospital, Barcelona, Spain

Status

Recruiting

Address

Vall d'Hebron General Hospital

Barcelona, ,

Site Contact

Albert Selva-O'Callaghan

[email protected]

1-617-963-0707

Hospital 12 Octubre, Madrid, Spain

Status

Recruiting

Address

Hospital 12 Octubre

Madrid, ,

Site Contact

Paloma Jimenez

[email protected]

1-617-963-0707

Stockholm, Sweden

Status

Recruiting

Address

Karolinska University Hospital, Rheumatology Clinic

Stockholm, ,

Site Contact

Ingrid Lundberg

[email protected]

+46 73 53 76 921

Klinik für Rheumatologie, St. Gallen, Switzerland

Status

Recruiting

Address

Klinik für Rheumatologie

St. Gallen, , 9007

Site Contact

Andrea Rubbert-Roth

[email protected]

1-617-963-0707

London, United Kingdom

Status

Recruiting

Address

King's College Hospital NHS Foundation Trust

London, ,

Site Contact

Patrick Gordon

[email protected]

1-617-963-0707

Salford Royal NHS Foundation Trust, Salford, United Kingdom

Status

Recruiting

Address

Salford Royal NHS Foundation Trust

Salford, , M6 8HD

Site Contact

Hector Chinoy

[email protected]

1-617-963-0707