Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Systemic Sclerosis



Status:Active, not recruiting
Conditions:Neurology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Neurology
Healthy:No
Age Range:18 - 70
Updated:1/31/2019
Start Date:August 2015
End Date:December 2021

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A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of JBT-101 in Diffuse Cutaneous Systemic Sclerosis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
efficacy of JBT-101 in adult subjects with diffuse cutaneous systemic sclerosis.

Part A of the study is an interventional, double-blind, randomized, placebo-control design
will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in
subjects ≥ 18 and ≤ 70 years of age with active diffuse cutaneous systemic sclerosis. The
screening period is up to 28 days, with 84 days treatment period and 28 days follow-up off
active treatment.

Part B of the study is an interventional, open-label design will be used. All subjects who
complete dosing in Part A without permanent discontinuation of study drug and who pass repeat
safety screening will be eligible for enrollment. The screening period is up to 28 days, with
a 364 day treatment period and 28 day follow up after last dose of JBT-101.

Inclusion Criteria:

Part A

- Diffuse cutaneous systemic sclerosis

- Have skin thickening from SSc in a body area suitable for repeat biopsy

- Disease duration ≤ 3 years from the first non-Raynaud's phenomenon or >3 years and ≤ 6
years from the first non-Raynaud's phenomenon and high sensitivity C-reactive protein
> 3 mg/L, high sensitivity interleukin-6 > 5 pg/mL, or increase in mRSS ≥ 5 points
over the last 6 months with total RSS ≥ 12.

- Stable treatment for SSc for at least 28 days before Visit 1

Part B

•Completion of dosing in Part A without permanent discontinuation of study product because
of safety or tolerability reasons.

Exclusion Criteria (Part A and B):

- Severe or unstable systemic sclerosis

- Significant diseases or conditions other than systemic sclerosis that may influence
response to the study product or safety;

- Any one of the following values for laboratory tests at Screening:

1. A positive pregnancy test (or at Visit 1);

2. Hemoglobin < 10 g/dL

3. Neutrophils < 1.0 x 10^9/L

4. Platelets < 75 x 10^9/L

5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation

6. Serum transaminases > 2.0 x upper normal limit

7. Total bilirubin ≥ 1.5 x upper limit of normal

- Any other condition that, in the opinion of the Principal Investigator, is clinically
significant and may put the subject at greater safety risk, influence response to
study product, or interfere with study assessments.
We found this trial at
9
sites
1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Principal Investigator: Robert W Simms, M.D
Phone: 617-638-5383
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Houston, Texas 77030
Principal Investigator: Maureen Mayes, M.D
Phone: 713-500-7118
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Tracy Frech, M.D.
Phone: 801-581-4993
University of Utah Research is a major component in the life of the U benefiting...
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Baltimore, Maryland 21224
Principal Investigator: Laura Hummers
Phone: 410-550-8582
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Los Angeles, California
Principal Investigator: Daniel Furst, M.D
Phone: 609-895-0735
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New Brunswick, New Jersey 08901
Principal Investigator: Vivien Hsu, M.D
Phone: 732-418-8478
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New York, New York 10021
Principal Investigator: Robert Spiera
Phone: 212-774-7194
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Palo Alto, California 94304
Principal Investigator: Lorinda Chung, M.D
Phone: 650-721-7147
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Robyn T Domsic, M.D
Phone: 412-648-7040
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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