- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349009
Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial
August 16, 2017 updated by: Prism Pharma Co., Ltd.
A Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial
1:1 active treatment: placebo, blinded trial, evaluating the effect of a 4-week treatment period with topical C-82 on skin expression of two gene biomarker surrogates (THBS1 and COMP) for the modified Rodnan skin score (MRSS).
Study subjects will be randomized to apply the active study medication daily for 4 weeks to either the right or left forearm and placebo to the contralateral forearm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
1:1 active treatment: placebo, blinded trial, evaluating the effect of a 4-week treatment period with topical C-82 on skin expression of two gene biomarker surrogates (THBS1 and COMP) for the modified Rodnan skin score (MRSS).
Study subjects will be randomized to apply the study medication daily for 4 weeks to either the right or left forearm.
All subjects will apply placebo (i.e., a topical gel without C-82) to the contralateral forearm.
Both physician and subject will be blinded to treatment arm assignment.
Skin biopsies will be taken from the mid-forearm of both arms at baseline and after four weeks of study drug to test for biomarker gene expression; instructions and supplies will be provided to each site.
Safety assessments will extend to 4 weeks after the final dose of study drug/placebo.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States
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-
Massachusetts
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Boston, Massachusetts, United States
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New York
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New York, New York, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- meet the American College of Rheumatology criteria for systemic sclerosis with diffuse cutaneous involvement (clinical skin involvement proximal to forearms and or knees, not including the face).
- Disease duration of <36 months since the onset of the first SSc manifestation other than Raynaud's phenomenon, or patients with progressive disease based on new or worsening skin disease based on physician assessment.
- local skin score over the bilateral forearm of ≥ 2.
- a MRSS of ≥ 12.
- on stable dose of any immunosuppressive other than cyclophosphamide or high dose steroids (excluded treatments) for at least one month and through the course of study treatment.
- Subjects of child-producing potential must agree to use effective contraception while and for at least 3 months after the last treatment.
Exclusion Criteria:
- Receiving treatment as part of an interventional clinical trial within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer).
- Ongoing use of high dose steroids (> 10mg/day prednisone or equivalent) or unstable steroid dose in the past 4 weeks.
- Use of topical creams or gels on the forearm area within the past month and through the course of study treatment.
- UV light therapy for 4 weeks before or during the study period.
- Treatment with cyclophosphamide within the past month and through the course of study treatment.
- Known active bacterial, viral fungal mycobacterial, or other infection
- history of malignancy within the past 2 years.
- Moderate to severe hepatic impairment, .
- Scleroderma renal crisis within 4 months or creatinine greater than 2.0.
- Pregnancy.
- Nursing mothers are to be excluded.
- Gastrointestinal involvement requiring total parenteral nutrition or hospitalization within the past 3 months for pseudo-obstruction
- Moderately severe pulmonary disease with FVC < 40%, or DLCO < 30% predicted or evidence of progressive lung disease as manifest by a decrease in FVC or 10% or more over the previous year.
- Moderately severe cardiac disease with clinically significant heart failure, or unstable angina.
- AST or ALT > 2.5 x Upper Limit of Normal.
- Total bilirubin > 1.5 x upper limit of normal (ULN). Patients with Gilbert's Disease may be included if their total bilirubin is ≤ 3.0 mg/dL.
- significant medical or psychosocial problems that warrant exclusion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
C-82 Topical Gel, Placebo
|
placebo
|
Active Comparator: Active
C-82 Topical Gel, 1%
|
active
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
frequency and character of adverse events and abnormal clinical tests
Time Frame: 28 days
|
28 days
|
change in gene biomarker expression of THBS1 and COMP in skin biopsies over time compared to placebo
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Lafyatis, MD, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
January 18, 2015
First Submitted That Met QC Criteria
January 22, 2015
First Posted (Estimate)
January 28, 2015
Study Record Updates
Last Update Posted (Actual)
August 17, 2017
Last Update Submitted That Met QC Criteria
August 16, 2017
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRI-C82T-3101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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