A clinical trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL)

Phase 1

• Conditions: Cutaneous T Cell Lymphoma; MedDRA version: 22.0Level: LLTClassification code 10028483Term: Mycosis fungoidesSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-001677-16-DE
• Lead Sponsor: Galderma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-09
• Study Completion: 2020-03-17
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. Adults = 18 years of age at the screening visit.

2. Have a clinical diagnosis of cutaneous T cell lymphoma (CTCL) stage IA, IB, or IIA including documentation of a skin biopsy within the last twelve (12) months with histological findings consistent with CTCL (Olsen et al, 2007). If the histological documentation is not available, a (non-target lesion) skin biopsy may be performed at the Screening visit for confirmation.

3. For stage IIA, only subjects with a classification of N0 (No clinically abnormal peripheral lymph nodes) or N1 (clinically abnormal lymph node(s) histopathology Dutch grade 1 or NCI LN0-2) can be enrolled.

4. Subjects must be B0 (absence of significant blood involvement: ?5% of peripheral blood lymphocytes or <250/mcL are atypical (Sezary) cells, fewer than 20% Sezary cells or fewer than 250 Sezary cells/µL.
One of the following can be substituted for Sezary cells: up to 1,600/µL CD4 cells and lower than 250/µL CD4+/CD26- or CD4+/CD7- cells

5. Subjects may only be included when therapies, according to the S2k – Leitlinie – Kutane Lymphome, Stand 08/2017, are either contraindicated and/or ineffective and/or not well tolerated.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

1. Participation in previous studies with resiquimod.

2. Known or suspected allergies or sensitivities to any component of the resiquimod gel.

3. History of clinically meaningful allergic reactions to imiquimod.

4. History of autoimmune disease including (but not limited to) rheumatoid arthritis, autoimmune hepatitis, autoimmune thyroiditis, Sjögren syndrome, psoriasis, or systemic lupus erythematosus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified