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



Status:Recruiting
Conditions:Neurology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Neurology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:December 18, 2017
End Date:March 2020
Contact:Lindsey Smith
Email:SScPatients@corbuspharma.com
Phone:1-617-963-0707

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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.


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.
We found this trial at
28
sites
Baltimore, Maryland 21224
Principal Investigator: Laura Hummers, MD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Soumya Chatterjee, RN
Phone: 216-444-3290
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Adelaide,
Principal Investigator: Susanna Proudman, MD
Phone: + 61 8 7074 4068
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Adelaide,
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Albany, New York 12203
Principal Investigator: Lee Shapiro, MD
Phone: 518-489-4471
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Principal Investigator: Vivek Nagaraja, MD
Phone: 734-232-2090
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13001 E 17th Pl
Aurora, Colorado 80045
(303) 724-5000
Principal Investigator: Aryeh Fischer, MD
Phone: 303-724-8403
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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Boston, Massachusetts 02118
Principal Investigator: Robert Simms, MD
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Boston, MA
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Boston, Massachusetts 02114
Principal Investigator: Flavia V Castelino, MD
Phone: 617-726-2000
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Edwin Smith, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: John Varga, MD
Phone: 312-503-1137
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Dallas, Texas 75231
Principal Investigator: Zoran Kurepa, MD, PhD
Phone: 214-424-0405
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Houston, Texas 77030
Principal Investigator: Maureen Mayes, MD
Phone: 713-500-7118
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Arthur Kavanaugh, MD
Phone: 858-246-2387
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Nicole M Orzechowski, DO
Phone: 603-650-8587
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Los Angeles, California 90045
Principal Investigator: Daniel E Furst, MD
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Suzanne Kafaja, MD
Phone: 310-825-9682
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Milwaukee, Wisconsin 53226
Principal Investigator: Mary Ellen Csuka, MD
Phone: 414-955-7007
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Minneapolis, Minnesota 55455
Principal Investigator: Jerry Molitor, MD, PhD
Phone: 612-626-8658
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New Brunswick, New Jersey 08901
Principal Investigator: Vivien M Hsu, MD
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New Orleans, Louisiana 70112
Principal Investigator: Lesley Saketkoo, MD, MPH
Phone: 504-988-4040
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Robert Spiera, MD
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Elana J Bernstein, MD, MSc
Phone: 212-342-2713
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Palo Alto, California 94304
Principal Investigator: Lorinda Chung, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Nora Sandorfi, MD
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Pittsburgh, Pennsylvania 15261
Principal Investigator: Robyn T Domsic, MD
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Salt Lake City, Utah 84132
Principal Investigator: Tracy Frech, MD
Phone: 801-581-4993
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
Principal Investigator: Bashar Kahaleh, MD
Phone: 419-383-6761
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Principal Investigator: Virginia Steen, MD
Phone: 202-444-6210
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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