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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292406
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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).

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)
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

Arm Intervention/treatment
Experimental: CD11301 Gel 0.06%
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.
Drug: CD11301 0.06%
Topical Gel

Experimental: CD11301 Gel 0.03%
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.
Drug: CD11301 0.03%
Topical Gel

Experimental: Placebo
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.
Drug: Placebo
Non active ingredients of CD11301

Drug: CD11301 0.03%
Topical Gel




Primary Outcome Measures :
  1. 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 [ Time Frame: Week 12 ]
    Overall response is defined as the number of participants that achieved a complete response (CR) or partial response (PR) as assessed by mCAILS. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity. Complete response is defined as a 100% decrease from baseline i.e. score of '0' on the mCAILS scale. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline.


Secondary Outcome Measures :
  1. Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12 [ Time Frame: Week 12 ]
    OR is defined as the number of participants that achieved a complete response or partial response as assessed by mSWAT. mSWAT composite score involved the direct assessment of the BSA of each type of lesion (palm plus fingers of the participant= approximately 1% BSA) in each of 12 areas (Head, Neck, Anterior trunk, Arms, Forearms, Hands, Posterior trunk, Buttocks, Thighs, Legs, Feet, Groin) of the body, multiplying the sum of the BSA of each lesion type by a weighting factor (patch = 1, plaque = 2, and tumor = 3 or 4) and generating a sum of the subtotals of each lesion subtype. mSWAT score (0=no lesions; 400= lesions covering all areas). Complete response is defined as a 100% decrease from baseline. Partial response is defined as at least a 50%, but less than 100%, decrease from baseline, and with a tumor subscore of zero (no tumor).

  2. Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score [ Time Frame: Up to Week 36 ]
    Time to overall response (CR or PR) is the number of days from the start of drug application to the first documentation of objective response assessed by mCAILS Score. The 25th, 50th, and 75th percentiles were presented along with 95% confidence intervals using the log-log transformation. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.

  3. Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score [ Time Frame: Up to Week 36 ]
    The duration of overall response (complete or partial) of the target treated lesions based on the mCAILS score was calculated in days as: (date of first non-response after responding) - (date of response) + 1. The mCAILS assessment total was derived from components collected on the case report form (CRF). Target treated lesions (1-5 lesions) were rated in erythema (0-8, where 0=no evidence and 8= very severe), scaling (0-8, where 0=no evidence and 8= very severe), plaque elevation (0-3, where 0=no evidence and 3= marked elevation), and size (scale=0-18, where 0= no measurable area and 18= size of lesion >300 centimeter [cm]^2). These 4 ratings were summed to create subtotals, 1 per lesion. The final mCAILS assessment score was the sum of these subtotals. Total summation Score: 0-50 where higher score indicated higher severity.

  4. Time to Progressive Disease Using mSWAT [ Time Frame: Up to Week 36 ]
    Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, Nadir is defined as the lowest skin score (best response).

  5. Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36 [ Time Frame: Week 12, 24 and Follow up (Week 36) ]
    Participants answered 30 questions as part of the Skindex-29 survey. A composite score and 3 sub scores were calculated from the results. Item 18 of the survey was not used in any scoring. First, answers to each item were given a numeric value: Never = 0; Rarely = 25; Sometimes = 50; Often = 75; All the time = 100. The items used to calculate each subscore were: Emotions: 3, 6, 9, 12, 13, 15, 21, 23, 26, and 28 (10 items), Symptoms: 1, 7, 10, 16, 19, 24, and 27 (7 items), Functioning: 2, 4, 5, 8, 11, 14, 17, 20, 22, 25, 29, and 30 (12 items). The composite score is the average of the 3 sub scores ranging from 0 (no effect)-100 (maximum effect), higher score corresponds to lower quality of life.



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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 participant 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


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
  Study Documents (Full-Text)

Documents provided by Galderma R&D:
Study Protocol  [PDF] March 25, 2019
Statistical Analysis Plan  [PDF] April 23, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Results First Posted: April 8, 2021
Last Update Posted: April 8, 2021
Last Verified: March 2021
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