An Open-label, Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Cutaneous Adverse Events Due to Checkpoint Inhibitors

Обзор

To assess the safety and efficacy of QD 0.3% topical roflumilast foam in patients with cutaneous adverse events due to checkpoint inhibitors over 16 weeks, with or without previous treatment.

Вмешательства

• Препарат Roflumilast 0.3% topical foam
  QD treatment with roflumilast 0.3% foam

Первичные конечные точки

• Percentage of patients achieving a 1+ point Change in CTCAE score at week 8 [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Male or female subjects aged 18 years or older.
• Life expectancy ≥ 36 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
• Participants are legally competent to sign and give informed consent.
• Patients receiving current or recent (within 6-months) treatment with immune checkpoint inhibitor(s).
• Diagnosis of Immune Checkpoint Inhibitor-Related Toxicities Mild (G1 or <10%), Moderate (G2 or 10-30% BSA), Severe (G3 or 30+ % BSA) using CTCAE v5.0 with the following: Maculopapular rash, pruritus, bullous dermatitis, eczematous rashes, lichenoid eruption, or Psoriasis/Psoriasiform.
• Agreement to NOT use topical and systemic corticosteroids for treatment of ICI-related toxicity during the study for first 2 weeks.
• Agreement to not use systemic or biologic immunomodulating therapies during trial term unless cutaneous toxicity is not responding to Roflumilast therapy within the first 4 weeks and toxicity severity increases to high-grade (grade 3-4).
• Agreement not to change the dose, form or type of antihistamines if on a stable dose for at least 1 month prior to baseline and not to initiate use of any new antihistamines during participation in the study.
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening and Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.
• Females of non-childbearing potential should either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy).
• Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Критерии исключения

• Subjects who have pre-existing non-cutaneous toxicities requiring systemic immunosuppression.
• Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table Excluded Medications and Treatments to be added).
• Oral or colitis toxicities associated with immune checkpoint inhibitor therapy at time of study enrollment.
• Subjects with any condition in the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• Subjects with known genetic dermatological conditions that overlap with cutaneous adverse events related to checkpoint inhibitor per investigator.
• Subjects with moderate to severe liver impairment (Child-Pugh B or C).
• Subjects with known allergies to excipients in Roflumilast foam (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphase and ceteth-10 phosphate).
• Subjects who cannot discontinue the use of systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously for 2 weeks prior to Baseline/Day 1 and during the study period.
• Subjects who have received oral roflumilast (Daxas®, Daliresp®) within 4 weeks prior to Baseline/ Day 1.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Previous treatment with Roflumilast cream or foam (any potency).
• Subjects with a history of a major surgery (excluding minor biopsies) within 4 weeks prior to Baseline/Day 1 or subjects who have a major surgery planned during the study.
• Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
• Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
• Subjects who are family members of the clinical study site, clinical study staff, or sponsor.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07639840 · ARQ-ICI-cirAE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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