Johns Hopkins University
Baltimore, Maryland, 21218, United States
NCT Number: NCT07714187
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21218, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: other protocol-defined criteria apply.
Topical gel
Other names: SBI-0145
Time frame: Baseline through Day 114
Time frame: After each treatment administration up to Day 114
Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.
Time frame: Up to 28 days
Time frame: Up to 28 days
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Time frame: Baseline through Day 114
Time frame: Baseline through Day 114
Time frame: Baseline, Day 114
Contact information is provided by the study sponsor or research team.
SecuraBio
Industry
A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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