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Trial of Topical C-82 in Systemic Sclerosis - A Phase I/II Biomarker and Safety Trial
Bu çalışma, cilde uygulanan (topikal) C-82 jelinin, yaygın deri tutulumu olan sistemik skleroz (systemic sclerosis) hastalarındaki güvenliğini ve biyobelirteçler üzerindeki etkisini plaseboyla karşılaştırarak incelemiştir. Çalışmaya, hastalık ölçütlerini karşılayan ve ön kol deri tutulumu belirli düzeyde olan hastalar dahil edilmiştir. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.