Description:
To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).
Clinical Trials /
A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)
NCT03292406
Related Conditions:
- Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Recruiting Status:
Completed
Phase:
Phase 2
Trial Eligibility
Document
Title
- Brief Title: A Safety, Efficacy and Pharmacokinetics Study of CD11301 for the Treatment of Cutaneous T-Cell Lymphoma (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 IDs
- ORG STUDY ID: RD.03.SPR.104003
- NCT ID: NCT03292406
Conditions
- Cutaneous T Cell Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Placebo | Placebo | |
| CD11301 0.03% | CD11301 Gel 0.03% | |
| CD11301 0.06% | CD11301 Gel 0.06% |
Purpose
To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel
vs. placebo for early stage CTCL (IA, IB, or IIA).
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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 |
| Safety Issue: | |
| Description: | 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
| Measure: | 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 |
| Safety Issue: | |
| Description: | 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). |
| Measure: | 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 |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score |
| Time Frame: | Up to Week 36 |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Time to Progressive Disease Using mSWAT |
| Time Frame: | Up to Week 36 |
| Safety Issue: | |
| Description: | 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). |
| Measure: | Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36 |
| Time Frame: | Week 12, 24 and Follow up (Week 36) |
| Safety Issue: | |
| Description: | 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. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Galderma R&D |
Trial Keywords
- T-Cell
- Lymphoma
- Cutaneous
- CTCL
Last Updated
April 7, 2021
