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

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ClinicalTrials.gov Identifier: NCT03292406

Recruitment Status : Completed

First Posted : September 25, 2017

Last Update Posted : November 20, 2020

Sponsor:

Information provided by (Responsible Party):

Galderma R&D

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cutaneous T Cell Lymphoma	Drug: Placebo Drug: CD11301 0.03% Drug: CD11301 0.06%	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	86 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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
Actual Study Start Date :	December 19, 2017
Actual Primary Completion Date :	March 17, 2020
Actual Study Completion Date :	March 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Cutaneous T-cell Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1 Placebo followed by CD11301 (0.03%) Topical Gel	Drug: Placebo Non active ingredients of CD11301 Drug: CD11301 0.03% Topical Gel
Experimental: Group 2 CD11301 (0.03%) Topical Gel	Drug: CD11301 0.03% Topical Gel
Experimental: Group 3 CD11301 (0.06%) Topical Gel	Drug: CD11301 0.06% Topical Gel

Outcome Measures

Primary Outcome Measures :

Overall response rate of target lesions at Week 12 based on CAILS score. [ Time Frame: Week 12 ]
Overall response rate (Complete and Partial Response) of target lesions based on the Composite Assessment of Index Lesion Severity (CAILS) score.

Secondary Outcome Measures :

Overall response rate based upon mSWAT composite score at Week 12. [ Time Frame: Week 12 ]
Overall response rate (Complete and Partial Response) based upon mSWAT composite score.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292406

Locations

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United States, California
Galderma Investigational Site
Orange, California, United States, 92868
Galderma Investigational Site
Palo Alto, California, United States, 94304
United States, Connecticut
Galderma Investigational Site
Farmington, Connecticut, United States, 06032
United States, Illinois
Galderma Investigational Site
Chicago, Illinois, United States, 60611
United States, Massachusetts
Galderma Investigational Site
Boston, Massachusetts, United States, 02115
United States, North Carolina
Galderma Investigational Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Galderma Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Galderma Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Galderma Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Galderma Investigational Site
Dallas, Texas, United States, 75231
Galderma Investigational Site
Houston, Texas, United States, 77030
France
Galderma Investigational Site
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310
Galderma Investigational Site
Nantes, Pays De La Loire, France, 44093
Galderma Investigational Site
Paris, Île-de-France, France, 75010
Germany
Galderma Investigational Site
Mannheim, Baden-Württemberg, Germany, 68167
Galderma Investigational Site
Wurzburg, Bavaria, Germany, 97080
Galderma Investigational Site
Krefeld, North Rhine-Westphalia, Germany, 47805
Galderma Investigational Site
Minden, North Rhine-Westphalia, Germany, 32429
Galderma Investigational Site
Münster, North Rhine-Westphalia, Germany, 48149
Galderma Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Galderma Investigational Site
Berlin, Germany, 10117

Sponsors and Collaborators

Galderma R&D

Investigators

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Study Director:	Galderma R&D	Galderma R&D

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3.

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Responsible Party:	Galderma R&D
ClinicalTrials.gov Identifier:	NCT03292406
Other Study ID Numbers:	RD.03.SPR.104003
First Posted:	September 25, 2017 Key Record Dates
Last Update Posted:	November 20, 2020
Last Verified:	August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No intent to share information.

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Galderma R&D:


T-Cell Lymphoma Cutaneous CTCL

Additional relevant MeSH terms:

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Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms	Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin

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