A Phase 1 interventional study of Duvelisib in Mycosis Fungoides and Cutaneous T-cell Lymphoma, sponsored by SecuraBio. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by SecuraBio · Phase 1, Interventional, and Treatment
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.
This study's planned enrollment of 30 is below the median of 34 across 321 interventional studies indexed under Mycosis Fungoides.
Browse Mycosis Fungoides studies →SecuraBio is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: other protocol-defined criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Duvelisib
Topical gel
Also known as: SBI-0145
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Duvelisib