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

NCT07639840 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ARQ-ICI-cirAE
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Immune-related Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving a 1+ point Change in CTCAE score at week 8

  8 weeks

Study Arms (1)

Roflumilast foam 0.3%

EXPERIMENTAL

Drug: Roflumilast 0.3% topical foam

Interventions

Roflumilast 0.3% topical foam DRUG

QD treatment with roflumilast 0.3% foam

Roflumilast foam 0.3%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Interventions

Roflumilast

Central Study Contacts

Yevgeniy Semenov, MD

CONTACT

617-723-6974; YSEMENOV@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-director, Oncodermatology Program, Department of Dermatology, Massachusetts General Hospital

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06