Clinical trial NCT03292406: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous T Cell Lymphoma
Keywords: T-Cell
Lymphoma
Cutaneous
CTCL
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy, safety and pharmacokinetics in participants 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.

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 participant is in exclusion period from a previous clinical trial

Primary outcomes:
measure: Number of Participants Reported Overall Response (Complete and Partial) of Target Treated Lesions Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12
timeFrame: Week 12
measure: Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score
timeFrame: Up to Week 36
measure: Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score
timeFrame: Up to Week 36
measure: Time to Progressive Disease Using mSWAT
timeFrame: Up to Week 36
measure: Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36
timeFrame: Week 12, 24 and Follow up (Week 36)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Galderma Investigational Site
state: California
city: Palo Alto
country: United States
facility: Galderma Investigational Site
state: California
city: Farmington
country: United States
facility: Galderma Investigational Site
state: Connecticut
city: Chicago
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Boston
country: United States
facility: Galderma Investigational Site
state: Massachusetts
city: Durham
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Galderma Investigational Site
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site
state: Texas
city: Pierre-Bénite
country: France
facility: Galderma Investigational Site
state: Auvergne-Rhône-Alpes
city: Nantes
country: France
facility: Galderma Investigational Site
state: Pays De La Loire
city: Paris
country: France
facility: Galderma Investigational Site
state: Île-de-France
city: Mannheim
country: Germany
facility: Galderma Investigational Site
state: Baden-Württemberg
city: Wurzburg
country: Germany
facility: Galderma Investigational Site
state: Bavaria
city: Krefeld
country: Germany
facility: Galderma Investigational Site
state: North Rhine-Westphalia
city: Minden
country: Germany
facility: Galderma Investigational Site
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: Galderma Investigational Site
state: North Rhine-Westphalia
city: Kiel
country: Germany
facility: Galderma Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Galderma Investigational Site
Study officials:
affiliation: Galderma R&D
name: Galderma R&D
role: STUDY_DIRECTOR
References:
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.