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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 : Recruiting
First Posted : September 25, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




Primary Outcome Measures :
  1. 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 :
  1. 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.



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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

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


Contacts
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Contact: Galderma R&D 817-961-5120 frnceclinicaltrials@galderma.com

Locations
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United States, California
Galderma Investigational Site Recruiting
Orange, California, United States, 92868
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Palo Alto, California, United States, 94304
Contact: Galderma Investigational Site         
United States, Connecticut
Galderma Investigational Site Recruiting
Farmington, Connecticut, United States, 06032
Contact: Galderma Investigational Site         
United States, Illinois
Galderma Investigational Site Recruiting
Chicago, Illinois, United States, 60611
Contact: Galderma Investigational Site         
United States, Massachusetts
Galderma Investigational Site Recruiting
Boston, Massachusetts, United States, 02115
Contact: Galderma Investigational Site         
United States, North Carolina
Galderma Investigational Site Recruiting
Durham, North Carolina, United States, 27710
Contact: Galderma Investigational Site         
United States, Pennsylvania
Galderma Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Galderma Investigational Site         
Galderma Investigational Site Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Galderma Investigational Site         
United States, Tennessee
Galderma Investigational Site Recruiting
Nashville, Tennessee, United States, 37204
Contact: Galderma Investigational Site         
United States, Texas
Galderma Investigational Site Recruiting
Dallas, Texas, United States, 75231
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact: Galderma Investigational Site         
Galderma Investigational Site Withdrawn
Pflugerville, Texas, United States, 78660
France
Galderma Investigational Site Recruiting
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Dijon, Bourgogne-Franche-Comté, France, 21079
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Bordeaux, Nouvelle-Aquitaine, France, 33604
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Nantes, Pays De La Loire, France, 44093
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Paris, Île-de-France, France, 75010
Contact: Galderma Investigational Site         
Germany
Galderma Investigational Site Recruiting
Mannheim, Baden-Württemberg, Germany, 68167
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Tuebingen, Baden-Württemberg, Germany, 72076
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Wurzburg, Bavaria, Germany, 97080
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Krefeld, North Rhine-Westphalia, Germany, 47805
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Minden, North Rhine-Westphalia, Germany, 32429
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Münster, North Rhine-Westphalia, Germany, 48149
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Galderma Investigational Site         
Galderma Investigational Site Recruiting
Berlin, Germany, 10117
Contact: Galderma Investigational Site         
Sponsors and Collaborators
Galderma R&D
Investigators
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Study Director: Galderma R&D Galderma R&D

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT03292406     History of Changes
Other Study ID Numbers: RD.03.SPR.104003
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: July 2018
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