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Clinical trials
catalyst calendar across sponsors →Studies where ARQT is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
25 interventional · 19 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234NCT07453602Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)Randomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Biological: ARQ-234 · Drug: Placebo | Atopic Dermatitis (AD), Eczema | 125 | Apr 2028 | ≤ 619 d | 2026-08-17 |
| Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body PsoriasisNCT07340216Concentration of Roflumilast and Roflumilast N-Oxide from plasmaOpen-label · Treatment | Phase 1 | Completed | Drug: ARQ-154 Foam 0.3% | Psoriasis | 22 | 2026-04-30actual | — | 2026-05-22 |
| Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic DermatitisNCT06998056Subject incidence of adverse eventsOpen-label · Treatment | Phase 2 | Completed | Drug: ARQ-151 cream 0.05% | Atopic Dermatitis (Eczema) | 101 | 2025-12-04actual | — | 2025-12-10 |
| Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic DermatitisNCT04804605results2025-12-23Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% | Atopic Dermatitis Eczema | 1,220 | 2024-05-28actual | — | 2025-12-23 |
| Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque PsoriasisNCT04286607Occurrence of treatment emergent AEs (TEAEs)Open-label · Treatment | Phase 3 | Completed | Drug: Topical roflumilast | Chronic Plaque Psoriasis | 333 | 2024-01-22actual | — | 2025-01-07 |
| Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)NCT04845620results2025-12-23Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roflumilast Cream 0.05%, Vehicle Cream | Atopic Dermatitis Eczema | 652 | 2023-06-01actual | — | 2025-12-23 |
| Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate EczemaNCT04156191Maximum Plasma Concentration (Cmax) of roflumilast and its N-oxide metaboliteOpen-label · Treatment | Phase 1 | Completed | Drug: ARQ-151 cream 0.15%, ARQ-151 cream 0.05% | Atopic Dermatitis (Eczema) | 101 | 2023-05-02actual | — | 2023-07-24 |
| Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic DermatitisNCT04445987results2024-06-11Number of Participants With ≥1 Adverse Event (AE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ARQ-154 | Seborrheic Dermatitis | 408 | 2022-11-19actual | — | 2024-06-11 |
| Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)NCT04773600results2024-10-04Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roflumilast Cream, Vehicle cream | Atopic Dermatitis Eczema | 683 | 2022-09-29actual | — | 2024-10-04 |
| Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic DermatitisNCT04773587results2024-10-09Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roflumilast Cream 0.15%, Vehicle Cream | Atopic Dermatitis Eczema | 654 | 2022-08-30actual | — | 2024-10-09 |
| Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)NCT05028582results2025-07-17Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roflumilast Foam 0.3%, Vehicle Foam | Scalp Psoriasis | 432 | 2022-06-03actual | — | 2025-07-17 |
| Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)NCT04746911results2026-08-07Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3%Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ARQ-151 cream 0.3% | Psoriasis, Plaque Psoriasis | 10 | 2022-05-11actual | — | 2026-08-07 |
| Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)NCT04973228results2024-03-12Achievement of Success on the Investigator Global Assessment (IGA) at Week 8Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roflumilast Foam, Vehicle Foam | Seborrheic Dermatitis | 457 | 2022-04-06actual | — | 2024-03-12 |
| Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)NCT04655313results2023-12-15Plasma Concentration of ARQ-151 Cream 0.3%Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: ARQ-151 cream 0.3% | Psoriasis, Plaque Psoriasis | 20 | 2022-01-12actual | — | 2023-12-15 |
| Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial VitiligoNCT04811131results2024-07-12Percentage of Participants Achieving 75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI) Score (F-VASI75) at Week 24Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: ARQ-252 cream 0.3%, ARQ-252 Vehicle cream · Device: NB-UVB phototherapy active treatment, NB-UVB phototherapy sham treatment | Vitiligo | 114 | 2021-08-09actual | — | 2024-07-12 |
| Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Adolescents and Adults With Chronic Plaque PsoriasisNCT04279119Maximum concentration (Cmax) of roflumilast and its major N-oxide metaboliteOpen-label · Treatment | Phase 1 | Completed | Drug: ARQ-151- cream 0.3% | Plaque Psoriasis | 26 | 2021-03-25actual | — | 2022-08-03 |
| Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand EczemaNCT04378569results2024-04-05Cohort 1: Number of Participants With ≥1 Adverse Event (AE)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: ARQ-252 cream 0.3%, ARQ-252 cream 0.1%, ARQ-252 Vehicle Cream | Chronic Hand Eczema | 230 | 2021-02-24actual | — | 2024-04-05 |
| Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque PsoriasisNCT04211389results2022-10-18Number of Participants Achieving Success on the Investigator Global Assessment (IGA) ScaleRandomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: ARQ-151 0.3% cream, ARQ-151 vehicle cream | Chronic Plaque Psoriasis | 442 | 2020-11-23actual | — | 2022-12-07 |
| Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque PsoriasisNCT04211363results2022-11-03Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Roflumilast 0.3% cream, Vehicle Cream | Chronic Plaque Psoriasis | 439 | 2020-11-16actual | — | 2022-12-07 |
| Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque PsoriasisNCT03764475results2022-08-18Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Roflumilast | Plaque Psoriasis | 332 | 2020-10-08actual | — | 2022-09-02 |
| Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body PsoriasisNCT04128007results2022-09-30Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) ScaleRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Roflumilast foam 0.3%, Vehicle foam | Plaque Psoriasis | 304 | 2020-09-23actual | — | 2022-10-26 |
| Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic DermatitisNCT04091646results2023-07-03Achievement of Investigator Global Assessment (IGA) Success at Week 8Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Roflumilast Foam 0.3%, Vehicle foam | Seborrheic Dermatitis | 226 | 2020-08-18actual | — | 2023-07-03 |
| Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic DermatitisNCT03916081results2023-02-13Mean Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Roflumilast Cream 0.05%, Roflumilast Cream 0.15%, Vehicle Cream | Atopic Dermatitis | 136 | 2019-11-04actual | — | 2023-02-13 |
| The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque PsoriasisNCT03638258results2022-08-10Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Roflumilast Cream 0.3%, Roflumilast Cream 0.15%, Vehicle Cream | Plaque Psoriasis | 331 | 2019-05-29actual | — | 2022-09-02 |
| Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque PsoriasisNCT03392168results2021-07-08Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Drug: ARQ-151 cream 0.5%, ARQ-151 cream 0.15%, ARQ-151 vehicle cream | Psoriasis | 91 | 2018-05-02actual | — | 2022-08-04 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19