A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)

• Status: Completed
• Trial end date: 2020-03-17
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D

Criteria

Inclusion Criteria:

• Clinical Diagnosis of CTCL stage IA, IB, or IIA with biopsy within last 3 months

• Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least 3 distinct lesions

Exclusion Criteria:

• CTCL that is stage IIB or great or stage IIA with stage N2 with >5% circulating Sezary cells or CD8+ or large cell transformation or Progressive CTCL

• History of autoimmune disease

• Laboratory test values at screening outside of the normal range and judged clinically significant by the investigator

• Current participation in another clinical trial of a drug or device or past participation within 4 weeks before Baseline or participant is in exclusion period from a previous clinical trial