This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Topical gel
Johns Hopkins University
Baltimore, Maryland, United States
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline through Day 114
Local Skin Reactions to Duvelisib Topical Gel
Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.
Time frame: After each treatment administration up to Day 114
Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel
Time frame: Up to 28 days
Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel
Time frame: Up to 28 days
Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Duvelisib Topical Gel
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Area Under the Curve (AUC) of Duvelisib Topical Gel
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Proportion of Treated Lesions Achieving >50% Improvement from Baseline Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score
Time frame: Baseline through Day 114
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Number of Participants Achieving a ≥50% Reduction from Baseline in Total mCAILS Score
Time frame: Baseline through Day 114
Change from Baseline in Total Modified Severity-weighted Assessment Tool (mSWAT) Score
Time frame: Baseline, Day 114