Phase 2 N=86 Randomized Double-blind Treatment

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

Cutaneous T Cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT03292406 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

Apr 2021

Primary outcome: 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 — 0; 2; 0; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); CD11301 0.03% (Drug); CD11301 0.06% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
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	0; 2; 0; 4; 5; 1	—
SECONDARY Number of Participants Reported Overall Response (OR) of Target Treated Lesions Based on Modified Severity-Weighted Assessment Tool (mSWAT) Score at Week 12	0; 0; 0; 6; 4; 2	—
SECONDARY Time to Participant's First Overall Response (Complete or Partial) of the Target Treated Lesions Based on the mCAILS Score	169; 85; NA; 197; NA; NA	—
SECONDARY Duration of Overall Response (Complete Response or Partial Response) Based on mCAILS Score	133; NA; NA; 141; NA; NA	—
SECONDARY Time to Progressive Disease Using mSWAT	NA; 191; 93; NA; NA; 93	—
SECONDARY Change From Baseline in Skindex-29 Survey Results at Week 12, 24 and 36	1.93; -0.27; -1.58; -2.16; -3.36; 0.58	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03292406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.