Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02349009
• Date of registration: 18/01/2015
• Prospective Registration: Yes
• Primary sponsor: Prism Pharma Co., Ltd.
• Public title: Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial
• Date of first enrolment: June 2015
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02349009
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Robert Lafyatis, MD
• Affiliation: Boston University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Scleroderma

Intervention(s)

Drug: C-82 Topical Gel, 1%

Drug: C-82 Topical Gel, Placebo

Primary Outcome(s)

change in gene biomarker expression of THBS1 and COMP in skin biopsies over time compared to placebo [Time Frame: 28 days]

frequency and character of adverse events and abnormal clinical tests [Time Frame: 28 days]

Secondary ID(s)

PRI-C82T-3101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors