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

NCT03292406 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: RD.03.SPR.104003
• Study Type: interventional
• Target: 86
• Locations: 3 countries
• Sites: 21

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).

Conditions

Cutaneous T Cell Lymphoma

Keywords

T-Cell; Lymphoma; Cutaneous; CTCL

Outcome Measures

Primary Outcomes (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

  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.

  Week 12

Secondary Outcomes (5)

• Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12

  Week 12

• Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score

  Up to Week 36

• Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score

  Up to Week 36

• Time to Progressive Disease Using mSWAT

  Up to Week 36

• Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36

  Week 12, 24 and Follow up (Week 36)

Study Arms (3)

CD11301 Gel 0.06%

EXPERIMENTAL

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%

CD11301 Gel 0.03%

EXPERIMENTAL

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%

Placebo

EXPERIMENTAL

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; Drug: CD11301 0.03%

Interventions

Placebo DRUG

Non active ingredients of CD11301

Placebo

CD11301 0.03% DRUG

Topical Gel

CD11301 Gel 0.03%; Placebo

CD11301 0.06% DRUG

Topical Gel

CD11301 Gel 0.06%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (21)

Galderma Investigational Site

Orange, California, 92868, United States

Location

Galderma Investigational Site

Palo Alto, California, 94304, United States

Location

Galderma Investigational Site

Farmington, Connecticut, 06032, United States

Location

Galderma Investigational Site

Chicago, Illinois, 60611, United States

Location

Galderma Investigational Site

Boston, Massachusetts, 02115, United States

Location

Galderma Investigational Site

Durham, North Carolina, 27710, United States

Location

Galderma Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Galderma Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Galderma Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Galderma Investigational Site

Dallas, Texas, 75231, United States

Location

Galderma Investigational Site

Houston, Texas, 77030, United States

Location

Galderma Investigational Site

Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

Location

Galderma Investigational Site

Nantes, Pays de la Loire Region, 44093, France

Location

Galderma Investigational Site

Paris, Île-de-France Region, 75010, France

Location

Galderma Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Galderma Investigational Site

Würzburg, Bavaria, 97080, Germany

Location

Galderma Investigational Site

Krefeld, North Rhine-Westphalia, 47805, Germany

Location

Galderma Investigational Site

Minden, North Rhine-Westphalia, 32429, Germany

Location

Galderma Investigational Site

Münster, North Rhine-Westphalia, 48149, Germany

Location

Galderma Investigational Site

Kiel, Schleswig-Holstein, 24105, Germany

Location

Galderma Investigational Site

Berlin, 10117, Germany

Location

Related Publications (1)

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

  PMID: 32632956 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Lymphoma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Galderma R&D

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 25, 2017
• Study Start: December 19, 2017
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); US (11); DE (7)