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

Cutaneous T Cell Lymphoma Clinical Trial

— CTCL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292406
• Other study ID #: RD.03.SPR.104003
• Status: Completed
• Phase: Phase 2
• Start date: December 19, 2017
• Est. completion date: March 17, 2020

Study information

• Verified date: March 2021
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous T Cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• Placebo
Non active ingredients of CD11301
• CD11301 0.03%
Topical Gel
• CD11301 0.06%
Topical Gel

Locations

Country	Name	City	State
France	Galderma Investigational Site	Nantes	Pays De La Loire
France	Galderma Investigational Site	Paris	Île-de-France
France	Galderma Investigational Site	Pierre-Bénite	Auvergne-Rhône-Alpes
Germany	Galderma Investigational Site	Berlin
Germany	Galderma Investigational Site	Kiel	Schleswig-Holstein
Germany	Galderma Investigational Site	Krefeld	North Rhine-Westphalia
Germany	Galderma Investigational Site	Mannheim	Baden-Württemberg
Germany	Galderma Investigational Site	Minden	North Rhine-Westphalia
Germany	Galderma Investigational Site	Münster	North Rhine-Westphalia
Germany	Galderma Investigational Site	Wurzburg	Bavaria
United States	Galderma Investigational Site	Boston	Massachusetts
United States	Galderma Investigational Site	Chicago	Illinois
United States	Galderma Investigational Site	Dallas	Texas
United States	Galderma Investigational Site	Durham	North Carolina
United States	Galderma Investigational Site	Farmington	Connecticut
United States	Galderma Investigational Site	Houston	Texas
United States	Galderma Investigational Site	Orange	California
United States	Galderma Investigational Site	Palo Alto	California
United States	Galderma Investigational Site	Philadelphia	Pennsylvania
United States	Galderma Investigational Site	Philadelphia	Pennsylvania
United States	Galderma Investigational Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at 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).	Week 12
Secondary	Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score	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.	Up to Week 36
Secondary	Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score	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.	Up to Week 36
Secondary	Time to Progressive Disease Using mSWAT	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).	Up to Week 36
Secondary	Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 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.	Week 12, 24 and Follow up (Week 36)