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

Galderma

Status and phase: Completed; Phase 2

Conditions: Cutaneous T Cell Lymphoma

Treatments: Drug: CD11301 0.03%; Drug: Placebo; Drug: CD11301 0.06%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03292406

RD.03.SPR.104003

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 3 patient groups

CD11301 Gel 0.06%

Experimental group

Description:

Participants applied 0.06% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Treatment:

Drug: CD11301 0.06%

CD11301 Gel 0.03%

Experimental group

Description:

Participants applied 0.03% CD11301 gel (up to 500 mg per dose) topically once daily, 3 to 5 times per week, for cycle 1 and 2 i.e. 24 weeks.

Treatment:

Drug: CD11301 0.03%

Placebo

Experimental group

Description:

Participants applied placebo gel during cycle one followed by 0.03% CD11301 gel topically during cycle two once daily, 3 to 5 times per week, for 24 weeks.

Treatment:

Drug: Placebo

Drug: CD11301 0.03%