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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cutaneous T Cell Lymphoma

In brief

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

Key facts

Study ID

NCT03292406

Run by

Galderma R&D

People needed

86

Starts

2017-12-19

Expected to finish

2020-03-17

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Galderma Investigational Site — Orange, California, United States
• Galderma Investigational Site — Palo Alto, California, United States
• Galderma Investigational Site — Farmington, Connecticut, United States
• Galderma Investigational Site — Chicago, Illinois, United States
• Galderma Investigational Site — Boston, Massachusetts, United States
• Galderma Investigational Site — Durham, North Carolina, United States
• Galderma Investigational Site — Philadelphia, Pennsylvania, United States
• Galderma Investigational Site — Philadelphia, Pennsylvania, United States
• Galderma Investigational Site — Pittsburgh, Pennsylvania, United States
• Galderma Investigational Site — Dallas, Texas, United States
• Galderma Investigational Site — Houston, Texas, United States
• Galderma Investigational Site — Pierre-Bénite, Auvergne-Rhône-Alpes, France
• Galderma Investigational Site — Nantes, Pays de la Loire Region, France
• Galderma Investigational Site — Paris, Île-de-France Region, France
• Galderma Investigational Site — Mannheim, Baden-Wurttemberg, Germany
• Galderma Investigational Site — Würzburg, Bavaria, Germany
• Galderma Investigational Site — Krefeld, North Rhine-Westphalia, Germany
• Galderma Investigational Site — Minden, North Rhine-Westphalia, Germany
• Galderma Investigational Site — Münster, North Rhine-Westphalia, Germany
• Galderma Investigational Site — Kiel, Schleswig-Holstein, Germany
• Galderma Investigational Site — Berlin, Germany

Full record on ClinicalTrials.gov

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