74 completed, 11 recruiting, 10 unknown, 7 terminated. 44 Phase 2, 34 Phase 3, 18 Phase 4, 17 Phase 1, 3 Early Phase 1.
Follow Roflumilast: new trials by email Literature Review of Roflumilast trials Research Report on Roflumilast
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis Phenotype Roflumilast Oral Tablet, Azithromycin 250 mg - Chronic Obstructive Pulmonary Disease With Exacerbation | Phase 4 | Not yet recruiting | Sidra Aziz | 70 | 2027-02-01 | 2026-08-31 |
| 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 Roflumilast 0.3% topical foam - Immune-related Dermatitis | Phase 2 | Not yet recruiting | Massachusetts General Hospital | 20 | 2026-11-01 | 2026-09-24 |
| Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients Placebo, Roflumilast - NAFLD (Nonalcoholic Fatty Liver Disease) | Phase 2 / Phase 3 | Not yet recruiting | Tanta University | 60 | 2026-11-01 | 2026-10-28 |
| An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis Roflumilast 0.3% topical cream - Chronic Plaque Psoriasis, Nail Psoriasis | Phase 4 | Recruiting | Modern Research Associates, PLLC | 15 | 2026-09-15 | 2026-10-01 |
| Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa Roflumilast 0.3% topical foam - Hidradenitis Suppurativa (HS) | Phase 2 | Recruiting | Harrison Dermatology | 10 | 2026-09-10 | 2026-10-13 |
| The Safety and Efficacy of Roflumilast Foam in HS Roflumilast 0.3% topical foam - Hidradenitis Suppurativa (HS) | Phase 2 | Recruiting | Beth Israel Deaconess Medical Center | 20 | 2026-09-01 | 2026-07-09 |
| Utilization of a Microdevice for Psoriasis and Atopic Dermatitis In situ cutaneous microdevice, Triamcinolone, 5-Fluorouracil - Psoriasis, Atopic Dermatitis | Phase 4 | Not yet recruiting | University of California, San Francisco | 10 | 2026-08-01 | 2026-06-03 |
| Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis Roflumilast 500 Mcg Oral Tablet, Placebo Group - Rheumatoid Arthritis, Rheumatoid Arthritis (RA) | Phase 2 | Recruiting | Horus University | 50 | 2026-05-19 | 2026-06-08 |
| Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis Roflumilast, Desloratadine, Placebo - Rheumatoid Arthritis | Phase 2 | Recruiting | Horus University | 90 | 2026-04-23 | 2026-05-12 |
| EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL. Methotrexate, Roflumilast 500 Mcg Oral Tablet - Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis | Phase 2 | Not yet recruiting | Eman Raafat Said | 56 | 2026-04-01 | 2026-04-22 |
| A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD Hemay005 tablets, Roflumilast Oral Tablet, Placebo tablet - COPD (Chronic Obstructive Pulmonary Disease) | Phase 2 | Not yet recruiting | Ganzhou Hemay Pharmaceutical Co., Ltd | 120 | 2026-01-01 | 2026-01-02 |
| Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study Oral roflumilast - Atopic Dermatitis | Phase 2 | Recruiting | Nora Mohamed Abdelrazik | 36 | 2025-11-20 | 2025-12-30 |
| A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa Topical roflumilast 0.3% foam - Hidradenitis Suppurativa | Phase 2 | Completed | Tulane University | 10 | 2025-09-25 | 2026-10-09 |
| A Pilot Study to Assess How Safe and Effective Oral Roflumilast is for Treating Moderate to Severe Psoriasis in Adults Oral roflumilast - Psoriasis (PsO) | Phase 2 | Recruiting | Ahmed Ibrahim | 36 | 2025-08-20 | 2025-12-02 |
| An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) Roflumilast topical 0.3% foam - Non-segmental Vitiligo | Phase 2 | Recruiting | Derm Texas, PLLC | 20 | 2025-08-01 | 2025-08-08 |
| Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL) Loncastuximab, Roflumilast, Rituximab - Diffuse Large B-cell Lymphoma | Phase 1 | Recruiting | The University of Texas Health Science Center at San Antonio | 10 | 2025-06-20 | 2026-09-29 |
| Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients Fluoxetine, Roflumilast, Placebo - Depressive Disorder, Major | Phase 3 | Recruiting | Tanta University | 60 | 2025-03-01 | 2026-05-04 |
| Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata Roflumilast, intralesional steroid - Alopecia, Alopecia Areata | Phase 4 | Completed | Cairo University | 50 | 2025-01-12 | 2025-09-15 |
| Roflumilast and TMS Motor Plasticity Roflumilast, Placebo, Intermittent theta-burst stimulation transcranial magnetic stimulation - Other Conditions of Brain | Phase 1 | Active not recruiting | University of Calgary | 20 | 2024-11-06 | 2025-07-03 |
| Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin Roflumilast, Vehicle (Roflumilast 0.3% vehicle cream) - Healthy Skin | Phase 4 | Unknown | Rao Dermatology | 3 | 2024-05-28 | 2024-06-03 |
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Pulmonary Disease, Chronic Obstructive (40) · Asthma (9) · Psoriasis (6) · Obesity (5) · Bronchiectasis (4) · Bronchitis, Chronic (3) · Diabetes Mellitus, Type 2 (3) · Hidradenitis Suppurativa (3) · Alzheimer Disease (2) · Arthritis, Rheumatoid (2) · Depressive Disorder, Major (2) · Dermatitis, Atopic (2) · Emphysema (2) · Lung Diseases (2) · Lymphoma, B-Cell (2)
AstraZeneca (35) · Tanta University (7) · Arcutis Biotherapeutics, Inc. (6) · Cairo University (3) · Johns Hopkins University (3) · The University of Texas Health Science Center at San Antonio (3) · Chiesi Farmaceutici S.p.A. (2) · FLUIDDA nv (2) · Horus University (2) · Maastricht University Medical Center (2) · The University of Hong Kong (2) · University Medical Centre Ljubljana (2) · University of Calgary (2) · Ahmed Ibrahim (1) · Anand B. Karnad (1)
United States (45) · Canada (18) · Egypt (14) · Germany (13) · United Kingdom (13) · Spain (11) · France (9) · South Africa (9) · Austria (8) · Poland (8) · Hungary (7) · Italy (7) · Netherlands (7) · Russia (7) · South Korea (6)
David Berk, MD (5) · Abeer Mohamed Elkholy, MD Dermatology (2) · Adolfo E Diaz Duque, MD (2) · Andrej Janez, MD, PhD (2) · Robert Wise, MD (2) · Adam Wanner, MD (1) · Ahmad Shaddad, Lecturer (1) · Alexander Egeberg, MD, PhD (1) · Alexander McGirr, MD PhD (1) · Anand Karnad, MD (1) · Anne Dixon, MD (1) · Anthony DeSoyza, MD (1) · Arjan Blokland, Prof. Dr. (1)
PMID 20102307, PMID 28419462, PMID 26498386, PMID 26612545, PMID 19716960, PMID 19716961, PMID 21272339, PMID 23117188, PMID 24120253, PMID 29763572, PMID 29797235, PMID 40862624, PMID 21631929, PMID 22029856, PMID 22791991, PMID 24135893, PMID 25684586, PMID 26032655, PMID 26151090, PMID 26296794, PMID 26456372, PMID 27585384, PMID 28146642, PMID 28679611, PMID 29098341, PMID 29241652, PMID 29579254, PMID 30224319, PMID 30536081, PMID 31213865, PMID 31354255, PMID 32725799, PMID 34744427, PMID 36125472, PMID 36170654, PMID 36189306, PMID 36422852, PMID 36719647, PMID 37077913, PMID 37465323, PMID 38438923, PMID 38592213, PMID 39594812, PMID 40311885, PMID 40403838, PMID 40574863, PMID 40940923, PMID 41134450, PMID 41194247, PMID 41256904
2005 (1), 2018 (1), 2023 (1), R01CA277493 (1), R34HL135361 (1), U54HD104461 (1)