Description:
To assess the efficacy, safety and pharmacokinetics in subjects treated with CD11301 gel vs.
placebo for early stage CTCL (IA, IB, or IIA).
Title
- Brief Title: A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
- Official Title: A Randomized, Double-blind, Multi-centre, Placebo-controlled, Parallel-arm Phase 2 Trial to Assess Safety, Efficacy and Pharmacokinetics of CD11301 0.03% and 0.06% Gel in the Treatment of Cutaneous T-Cell Lymphoma (CTCL), Stages IA, IB and IIA
Clinical Trial IDs
- ORG STUDY ID:
RD.03.SPR.104003
- NCT ID:
NCT03292406
Conditions
- Cutaneous T Cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Placebo | | Group 1 |
CD11301 0.03% | | Group 1 |
CD11301 0.06% | | Group 3 |
Purpose
To assess the efficacy, safety and pharmacokinetics in subjects treated with CD11301 gel vs.
placebo for early stage CTCL (IA, IB, or IIA).
Detailed Description
To assess the efficacy and safety of two concentrations (0.03% and 0.06%) of CD11301 gel in
the treatment of early stage CTCL (stage IA, IB, or IIA) versus placebo.
Trial Arms
Name | Type | Description | Interventions |
---|
Group 1 | Experimental | Placebo followed by CD11301 (0.03%) Topical Gel | |
Group 2 | Experimental | CD11301 (0.03%) Topical Gel | |
Group 3 | Experimental | CD11301 (0.06%) Topical Gel | |
Eligibility 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 subject is in exclusion period from a
previous clinical trial
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate of target lesions at Week 12 based on CAILS score. |
Time Frame: | Week 12 |
Safety Issue: | |
Description: | Overall response rate (Complete and Partial Response) of target lesions based on the Composite Assessment of Index Lesion Severity (CAILS) score. |
Secondary Outcome Measures
Measure: | Overall response rate based upon mSWAT composite score at Week 12. |
Time Frame: | Week 12 |
Safety Issue: | |
Description: | Overall response rate (Complete and Partial Response) based upon mSWAT composite score. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Galderma R&D |
Trial Keywords
- T-Cell
- Lymphoma
- Cutaneous
- CTCL
Last Updated