Mycosis FungoidesPhase 1NCT07714187
A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides
A Phase 1 study testing Duvelisib in people with Mycosis Fungoides and Cutaneous T-cell Lymphoma, run by SecuraBio at 1 site in United States.
Trial summary
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides, Cutaneous T-cell Lymphoma
- What is being tested?
- Duvelisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of Stage IA, Stage IB, or Stage IIA mycosis fungoides (cutaneous T-cell lymphoma), without clinically significant lymphadenopathy (≥1.5 centimeters).
- Have 3 to 5 active, treatment-accessible mycosis fungoides lesions; ulcerated lesions and lesions to the face, neck, inguinal folds and intergluteal cleft are not considered suitable for administration of study drug.
- Have baseline organ function (without transfusion support within 30 days of Cycle 1 Day 1) as defined by the protocol.
Who cannot join
- Have Stage IIB to IVB mycosis fungoides or Sezary syndrome.
- Have histopathologically confirmed lymph node involvement.
- Received systemic treatment with a phosphoinositide 3-kinases inhibitor in the 60 days prior to starting study drug.
- Received topical steroids or other topical treatment (for example, nitrogen mustard) on mycosis fungoides lesions in the 2 weeks prior to starting study drug. Participants who receive such agents may become eligible for the study after a 14-day washout period.
- Received systemic steroids, immunosuppressants (for example, cyclosporine, prednisone), psoralen ultraviolet A radiation therapy, narrow-band ultraviolet B light therapy, carmustine or other systemic therapies for mycosis fungoides in the 3 weeks prior to starting study drug.
- Received electron beam irradiation within the 3 months prior to starting study drug.
- Note: other protocol-defined criteria apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
- Conditions
- Mycosis Fungoides, Cutaneous T-cell Lymphoma
- Being tested
- Duvelisib
- Keywords
- Early-stage mycosis fungoides, Duvelisib, Topical
- Medical subject headings
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Also called SBI-0145
Topical gel
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib | Experimental | Not described Receives: Drug: Duvelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: 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.
Measured: After each treatment administration up to Day 114
Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel
Measured: Up to 28 days
Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel
Measured: Up to 28 days
Secondary outcomes (7)
Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel
Measured: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel
Measured: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Duvelisib Topical Gel
Measured: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Area Under the Curve (AUC) of Duvelisib Topical Gel
Measured: 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
Measured: Baseline through Day 114
Number of Participants Achieving a ≥50% Reduction from Baseline in Total mCAILS Score
Measured: Baseline through Day 114
Change from Baseline in Total Modified Severity-weighted Assessment Tool (mSWAT) Score
Measured: Baseline, Day 114
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reuven Chantre, MD, Study director, Secura Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714187
- Sponsor's protocol ID
- SBI-0145-C101
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No