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NCT Number: NCT07714187

A Study of Topical Duvelisib in Participants 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Treatment and study plan

Duvelisib

Drug

Topical gel

Other names: SBI-0145

Primary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline through Day 114

  2. Local Skin Reactions to Duvelisib Topical Gel

    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.

  3. Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel

    Time frame: Up to 28 days

  4. Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel

    Time frame: Up to 28 days

Secondary outcomes

  1. Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel

    Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)

  2. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel

    Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)

  3. 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)

  4. 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)

  5. 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

  6. Number of Participants Achieving a ≥50% Reduction from Baseline in Total mCAILS Score

    Time frame: Baseline through Day 114

  7. Change from Baseline in Total Modified Severity-weighted Assessment Tool (mSWAT) Score

    Time frame: Baseline, Day 114

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

1-858-251-1414

Sponsors and collaborators

Lead sponsor

SecuraBio

Industry

Registry information

Official study title

A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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