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

• 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: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• 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

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.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT03292406
• Other Study ID Numbers: RD.03.SPR.104003
• First Posted: September 25, 2017
• 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.

• 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:

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