Immune-related DermatitisPhase 2NCT07639840
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
A Phase 2 study testing Roflumilast 0.3% topical foam in people with Immune-related Dermatitis, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-related Dermatitis
- What is being tested?
- Roflumilast 0.3% topical foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Roflumilast 0.3% topical foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 0.3% topical foamDrug
QD treatment with roflumilast 0.3% foam
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast foam 0.3% | Experimental | Not described Receives: Drug: Roflumilast 0.3% topical foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving a 1+ point Change in CTCAE score at week 8
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-related DermatitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yevgeniy Semenov, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639840
- Sponsor's protocol ID
- ARQ-ICI-cirAE
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07639840
- Acronym / sponsor ID
- ARQ-ICI-cirAE
- Conditions
- Immune-related Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roflumilast foam 0.3% | Experimental | Drug: Roflumilast 0.3% topical foam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast 0.3% topical foamQD treatment with roflumilast 0.3% foam | Drug | Roflumilast foam 0.3% |
Primary outcome
Percentage of patients achieving a 1+ point Change in CTCAE score at week 8
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast 0.3% topical foam in people with Immune-related Dermatitis, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yevgeniy Semenov, MD (617-723-6974, YSEMENOV@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving a 1+ point Change in CTCAE score at week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.