Clinical Trials /

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

NCT03292406

Description:

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

Related Conditions:
  • Primary Cutaneous T Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
PlaceboGroup 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

NameTypeDescriptionInterventions
Group 1ExperimentalPlacebo followed by CD11301 (0.03%) Topical Gel
  • Placebo
  • CD11301 0.03%
Group 2ExperimentalCD11301 (0.03%) Topical Gel
  • CD11301 0.03%
Group 3ExperimentalCD11301 (0.06%) Topical Gel
  • CD11301 0.06%

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

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