Numerous clinical trials spanning Phase 1 through Phase 4 have evaluated roflumilast across various inflammatory, dermatological, and hematologic conditions, including plaque psoriasis, atopic dermatitis, chronic obstructive pulmonary disease, hidradenitis suppurativa, chronic hand eczema, and diffuse large B-cell lymphoma. Sponsored by pharmaceutical entities like Arcutis Biotherapeutics Inc. as well as academic institutions such as Cairo University and Beth Israel Deaconess Medical Center, these studies range in status from completed to actively recruiting. Collectively, this extensive research portfolio demonstrates the broad therapeutic investigation of roflumilast in mitigating severe inflammatory pathologies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06643221 | RECRUITING | Leukemia; Hematopoetic Stem Cell Transplantation; Donor Lymphocyte Infusion; CAR T-Cell Therapy; Lymphoma; Cell Therapy |
University of Arizona |
2018-01-24 | EARLY_PHASE1 |
| NCT07352566 | NOT_YET_RECRUITING | Psoriasis; Atopic Dermatitis |
University of California, San Francisco |
2026-08-01 | PHASE4 |
| NCT07263230 | RECRUITING | Hidradenitis Suppurativa (HS) |
Beth Israel Deaconess Medical Center |
2026-09-01 | PHASE2 |
| NCT07689188 | NOT_YET_RECRUITING | Hidradenitis Suppurativa (HS) |
Harrison Dermatology |
2026-08-10 | PHASE2 |
| NCT07314242 | NOT_YET_RECRUITING | COPD (Chronic Obstructive Pulmonary Disease) |
Ganzhou Hemay Pharmaceutical Co., Ltd |
2026-01-01 | PHASE2 |
| NCT07639840 | NOT_YET_RECRUITING | Immune-related Dermatitis |
Massachusetts General Hospital |
2026-08-01 | PHASE2 |
| NCT07560618 | RECRUITING | ITCH; Atopic Dermatitis |
Integrative Skin Science and Research |
2026-07-21 | PHASE4 |
| NCT07725822 | NOT_YET_RECRUITING | Chronic Plaque Psoriasis; Nail Psoriasis |
Modern Research Associates, PLLC |
2026-08 | PHASE4 |
| NCT07683806 | NOT_YET_RECRUITING | Seborrheic Dermatitis |
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
2026-08-24 | PHASE3 |
| NCT07566351 | RECRUITING | Rheumatoid Arthritis |
Horus University |
2026-04-23 | PHASE2 |
| NCT06860958 | RECRUITING | Depressive Disorder, Major |
Tanta University |
2025-03-01 | PHASE3 |
| NCT07795086 | NOT_YET_RECRUITING | Chronic Obstructive Pulmonary Disease With Exacerbation |
Sidra Aziz |
2027-02 | PHASE4 |
| NCT05796271 | WITHDRAWN | Lymphoma, B-Cell |
The University of Texas Health Science Center at San Antonio |
2024-01 | PHASE1 |
| NCT06977711 | RECRUITING | Diffuse Large B-cell Lymphoma |
The University of Texas Health Science Center at San Antonio |
2025-06-20 | PHASE1 |
| NCT07632846 | RECRUITING | Rheumatoid Arthritis; Rheumatoid Arthritis (RA) |
Horus University |
2026-05-19 | PHASE2 |
| NCT07077902 | RECRUITING | Hidradenitis Suppurativa |
Tulane University |
2025-09-25 | PHASE2 |
| NCT07543640 | NOT_YET_RECRUITING | Flexural Psoriasis (Also Known as Inverse or Intertriginous Psoriasis) and Genital Psoriasis |
Eman Raafat Said |
2026-04-01 | PHASE2 |
| NCT07297602 | RECRUITING | Atopic Dermatitis |
Nora Mohamed Abdelrazik |
2025-11-20 | PHASE2 |
| NCT07105254 | RECRUITING | Non-segmental Vitiligo |
Derm Texas, PLLC |
2025-08-01 | PHASE2 |
| NCT04069312 | COMPLETED | Chronic Obstructive Pulmonary Disease Severe; Chronic Bronchitis |
Johns Hopkins University |
2020-02-11 | PHASE3 |
| NCT07233291 | RECRUITING | Psoriasis (PsO) |
Ahmed Ibrahim |
2025-08-20 | PHASE2 |
| NCT04636814 | TERMINATED | Chronic Obstructive Pulmonary Disease |
Chiesi Farmaceutici S.p.A. |
2021-07-12 | PHASE3 |
| NCT06998056 | COMPLETED | Atopic Dermatitis (Eczema) |
Arcutis Biotherapeutics, Inc. |
2025-06-09 | PHASE2 |
| NCT05418049 | ACTIVE_NOT_RECRUITING | Fragile X Syndrome |
Children's Hospital Medical Center, Cincinnati |
2022-09-08 | PHASE2 |
| NCT06648772 | COMPLETED | Plaque Psoriasis |
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
2024-11-14 | PHASE3 |
| NCT06457191 | ACTIVE_NOT_RECRUITING | Other Conditions of Brain |
University of Calgary |
2024-11-06 | PHASE1 |
| NCT05682859 | COMPLETED | Chronic Hand Eczema |
Jacob Pontoppidan Thyssen |
2023-09-25 | PHASE4 |
| NCT06631170 | COMPLETED | Atopic Dermatitis (AD) |
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
2024-11-21 | PHASE3 |
| NCT07174011 | COMPLETED | Alopecia; Alopecia Areata |
Cairo University |
2025-01-12 | PHASE4 |
| NCT04751071 | WITHDRAWN | Major Depressive Disorder |
Sadat City University |
2021-02-01 | PHASE1; PHASE2 |
| NCT06677788 | COMPLETED | Non-Alcoholic Steatohepatitis (NASH) |
Tanta University |
2022-04-01 | PHASE2 |
| NCT04322929 | COMPLETED | Non-cystic Fibrosis Bronchiectasis |
The University of Hong Kong |
2020-11-12 | PHASE2 |
| NCT06440473 | UNKNOWN | Healthy Skin |
Rao Dermatology |
2024-05-28 | PHASE4 |
| NCT05684484 | COMPLETED | Ulcerative Colitis |
Tanta University |
2023-02-01 | PHASE4 |
| NCT04286607 | COMPLETED | Chronic Plaque Psoriasis |
Arcutis Biotherapeutics, Inc. |
2020-02-12 | PHASE3 |
| NCT04854811 | COMPLETED | Cerebrovascular Disorders; Memory; Functional Recovery; Drug Intervention |
Maastricht University |
2021-07-07 | PHASE2 |
| NCT05884281 | UNKNOWN | Peripheral Neuropathy |
Mansoura University |
2023-07 | PHASE1; PHASE2 |
| NCT05369793 | COMPLETED | Type 2 Diabetes (Adult Onset); Diabetic Neuropathies |
Tanta University |
2022-08-01 | PHASE3 |
| NCT04658654 | UNKNOWN | Mild Cognitive Impairment; Mild Dementia; Amnestic Mild Cognitive Disorder |
Maastricht University Medical Center |
2021-11-19 | PHASE2 |
| NCT04369547 | WITHDRAWN | Synaptic Plasticity |
University of Calgary |
2022-01 | PHASE1 |
| NCT05763082 | COMPLETED | Plaque Psoriasis |
Padagis LLC |
2023-02-07 | PHASE3 |
| NCT04845620 | COMPLETED | Atopic Dermatitis Eczema |
Arcutis Biotherapeutics, Inc. |
2021-04-07 | PHASE3 |
| NCT05684744 | COMPLETED | Psoriasis |
Cairo University |
2023-01-09 | PHASE2; PHASE3 |
| NCT05278624 | COMPLETED | Rosacea |
Dermatology Consulting Services, PLLC |
2022-04-15 | PHASE2 |
| NCT05684744 | Completed | Psoriasis |
Cairo University |
2023-01-09 | Phase 2|Phase 3 |
| NCT04549870 | COMPLETED | Psoriasis |
Bispebjerg Hospital |
2021-01-01 | PHASE2 |
| NCT04108377 | TERMINATED | Asthma |
University of California, Davis |
2019-01-21 | PHASE1 |
| NCT04773600 | COMPLETED | Atopic Dermatitis Eczema |
Arcutis Biotherapeutics, Inc. |
2021-02-24 | PHASE3 |
| NCT04773587 | COMPLETED | Atopic Dermatitis Eczema |
Arcutis Biotherapeutics, Inc. |
2021-01-27 | PHASE3 |
| NCT05028582 | COMPLETED | Scalp Psoriasis |
Arcutis Biotherapeutics, Inc. |
2021-08-24 | PHASE3 |
| NCT04973228 | COMPLETED | Seborrheic Dermatitis |
Arcutis Biotherapeutics, Inc. |
2021-07-08 | PHASE3 |
| NCT04800172 | COMPLETED | Obesity; PreDiabetes |
Tanta University |
2021-05-01 | PHASE3 |
| NCT03458546 | COMPLETED | Lymphoma, B-Cell |
The University of Texas Health Science Center at San Antonio |
2018-05-21 | PHASE1 |
| NCT04744090 | COMPLETED | Respiratory Distress Syndrome, Adult |
Cairo University |
2021-03-21 | PHASE2 |
| NCT03532490 | COMPLETED | Asthma; Obesity |
Johns Hopkins University |
2018-08-03 | PHASE2 |
| NCT04755946 | UNKNOWN | Diabetic Nephropathies |
Tanta University |
2021-03-10 | PHASE3 |
| NCT03988816 | UNKNOWN | Bronchiectasis Adult |
University of Sao Paulo General Hospital |
2019-12-06 | PHASE2 |
| NCT04211363 | COMPLETED | Chronic Plaque Psoriasis |
Arcutis Biotherapeutics, Inc. |
2019-12-20 | PHASE3 |
| NCT04655313 | Completed | Psoriasis|Plaque Psoriasis |
Arcutis Biotherapeutics Inc. |
2020-11-30 | Phase 2 |
| NCT03764475 | COMPLETED | Plaque Psoriasis |
Arcutis Biotherapeutics, Inc. |
2018-12-18 | PHASE2 |
| NCT04128007 | COMPLETED | Plaque Psoriasis |
Arcutis Biotherapeutics, Inc. |
2020-01-13 | PHASE2 |
| NCT04090294 | UNKNOWN | Bronchiectasis |
Assiut University |
2019-10-01 | EARLY_PHASE1 |
| NCT04091646 | COMPLETED | Seborrheic Dermatitis |
Arcutis Biotherapeutics, Inc. |
2019-12-04 | PHASE2 |
| NCT04279119 | Completed | Plaque Psoriasis |
Arcutis Biotherapeutics Inc. |
2020-03-10 | Phase 1 |
| NCT04156191 | Completed | Atopic Dermatitis (Eczema) |
Arcutis Biotherapeutics Inc. |
2019-12-23 | Phase 1 |
| NCT03916081 | COMPLETED | Atopic Dermatitis |
Arcutis Biotherapeutics, Inc. |
2019-05-31 | PHASE2 |
| NCT02743377 | COMPLETED | Nervous System Disease |
National Institute of Mental Health (NIMH) |
2018-04-04 | PHASE1; PHASE2 |
| NCT03428334 | COMPLETED | Non-cystic Fibrosis Bronchiectasis |
The University of Hong Kong |
2018-05-10 | PHASE2 |
| NCT03638258 | COMPLETED | Plaque Psoriasis |
Arcutis Biotherapeutics, Inc. |
2018-09-21 | PHASE2 |
| NCT03762330 | Unknown status | Chronic Obstructive Pulmonary Disease |
Fundacio d''Investigacio en Atencio Primaria Jordi Gol i Gurina|Institut Catala de Salut |
2019-01-19 | Not Applicable |
| NCT02671942 | TERMINATED | Chronic Obstructive Pulmonary Disease |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2016-03 | PHASE2 |
| NCT01973998 | COMPLETED | COPD |
Temple University |
2013-11 | PHASE3 |
| NCT02451540 | TERMINATED | Pulmonary Disease, Chronic Obstructive |
FLUIDDA nv |
2015-09 | PHASE2 |
| NCT01862029 | COMPLETED | Obesity |
National Heart, Lung, and Blood Institute (NHLBI) |
2013-05-22 | PHASE1; PHASE2 |
| NCT02363335 | COMPLETED | Healthy Volunteers |
National Institute on Aging (NIA) |
2015-02-13 | PHASE1 |
| NCT02340520 | COMPLETED | COPD |
UConn Health |
2014-12 | PHASE3 |
| NCT01745848 | COMPLETED | Chronic Obstructive Pulmonary Disease |
University of Pittsburgh |
2013-02 | PHASE4 |
| NCT01830959 | UNKNOWN | Sarcoidosis |
University of Cincinnati |
2013-04 | PHASE4 |
| NCT01509677 | COMPLETED | COPD; Chronic Obstructive Pulmonary Disease |
AstraZeneca |
2012-02-01 | PHASE3 |
| NCT01630200 | COMPLETED | Chronic Obstructive Pulmonary Disease and Allied Conditions |
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology |
2012-05 | PHASE4 |
| NCT04122547 | COMPLETED | Exacerbation Copd; Bronchiectasis; Lung Function Decreased |
Prince of Songkla University |
2015-01 | PHASE3 |
| NCT02018432 | UNKNOWN | Chronic Obstructive Pulmonary Disease |
Asan Medical Center |
2013-12 | PHASE4 |
| NCT01443845 | COMPLETED | COPD; COPD Exacerbation; Lung Diseases; Respiratory Disorders; Pulmonary Disease; Chronic Obstructive Lung Diseases; Chronic Obstructive Airway Disease |
AstraZeneca |
2011-09-30 | PHASE4 |
| NCT02165826 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
AstraZeneca |
2014-05-01 | PHASE3 |
| NCT02097992 | COMPLETED | COPD |
University of Miami |
2013-02 | PHASE1; PHASE2 |
| NCT02079844 | COMPLETED | Schizophrenia |
Takeda |
2014-03 | PHASE1 |
| NCT03073798 | COMPLETED | COPD; Chronic Bronchitis; Emphysema |
Johns Hopkins University |
2013-03-18 | PHASE4 |
| NCT01888952 | COMPLETED | Advanced B-cell Lymphoid Malignancies |
Anand B. Karnad |
2013-07 | EARLY_PHASE1 |
| NCT01701934 | TERMINATED | Chronic Obstructive Pulmonary Disease; Metabolic Syndrome |
Laval University |
2013-02 | PHASE2 |
| NCT01703260 | TERMINATED | Nonalcoholic Steatohapatitis |
AstraZeneca |
2013-06 | PHASE2 |
| NCT01572948 | COMPLETED | COPD |
University of Alabama at Birmingham |
2012-06 | |
| NCT02187250 | COMPLETED | PCOS; Obesity |
University Medical Centre Ljubljana |
2014-03 | PHASE4 |
| NCT02051335 | COMPLETED | Memory Impairment; Alzheimer's Disease |
AstraZeneca |
2014-01 | PHASE1 |
| NCT01329029 | COMPLETED | Chronic Obstructive Pulmonary Disease |
AstraZeneca |
2011-05 | PHASE4 |
| NCT01856764 | COMPLETED | Atopic Dermatitis |
AstraZeneca |
2013-06 | PHASE2 |
| NCT01473758 | TERMINATED | Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation |
AstraZeneca |
2012-02 | PHASE2 |
| NCT01849341 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
Fundación Pública Andaluza Progreso y Salud |
2012-07 | PHASE4 |
| NCT02037672 | COMPLETED | PCOS; Obesity |
University Medical Centre Ljubljana |
2013-09 | PHASE4 |
| NCT01730404 | COMPLETED | COPD |
Chiesi Farmaceutici S.p.A. |
2012-10 | PHASE2 |
| NCT01765192 | COMPLETED | Asthma |
AstraZeneca |
2013-02 | PHASE2 |
| NCT01480661 | COMPLETED | Pulmonary Disease, Chronic Obstructive |
FLUIDDA nv |
2011-12 | PHASE4 |
| NCT01580748 | UNKNOWN | Symptomatic Bronchiectasis |
Seoul National University Bundang Hospital |
2012-05 | PHASE2 |
| NCT01664624 | COMPLETED | Type 2 Diabetes |
AstraZeneca |
2012-07 | PHASE1 |
| NCT01433666 | COMPLETED | Dementia |
Maastricht University Medical Center |
2011-09 | PHASE2 |
| NCT01595750 | UNKNOWN | Chronic Obstructive Pulmonary Disease |
Spanish Research Center for Respiratory Diseases |
2012-05 | PHASE4 |
| NCT01313494 | COMPLETED | COPD |
AstraZeneca |
2011-03 | PHASE3 |
| NCT01354782 | COMPLETED | Chronic Obstructive Pulmonary Disease |
AstraZeneca |
2011-05 | PHASE1 |
| NCT00746382 | WITHDRAWN | Dermatitis |
AstraZeneca |
2008-11 | PHASE2 |
| NCT00746434 | WITHDRAWN | Plaque Psoriasis |
AstraZeneca |
2008-11 | PHASE2 |
| NCT00297102 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
AstraZeneca |
2006-02 | PHASE3 |
| NCT00297115 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
AstraZeneca |
2006-03 | PHASE3 |
| NCT00424268 | COMPLETED | Chronic Obstructive Pulmonary Disease |
AstraZeneca |
2007-01 | PHASE3 |
| NCT01140542 | COMPLETED | Diabetes Mellitus Type 2 |
AstraZeneca |
2006-08 | PHASE2 |
| NCT00313209 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
AstraZeneca |
2006-04 | PHASE3 |
| NCT00242320 | COMPLETED | COPD |
AstraZeneca |
2005-08 | PHASE3 |
| NCT00246922 | COMPLETED | Bronchial Asthma |
AstraZeneca |
2004-12-01 | PHASE3 |
| NCT00246935 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
AstraZeneca |
2005-05 | PHASE3 |
| NCT00242307 | COMPLETED | Bronchial Asthma |
AstraZeneca |
2004-05-01 | PHASE2; PHASE3 |
| NCT00242294 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
AstraZeneca |
2004-11 | PHASE2; PHASE3 |
| NCT00076089 | COMPLETED | Chronic Obstructive Pulmonary Disease; COPD |
AstraZeneca |
2003-12 | PHASE3 |
| NCT00163527 | COMPLETED | Asthma |
AstraZeneca |
2003-04 | PHASE3 |
| NCT00163475 | COMPLETED | Asthma |
AstraZeneca |
2004-05 | PHASE3 |
| NCT01365533 | COMPLETED | Allergic Asthma |
AstraZeneca |
2004-12 | PHASE2 |
| NCT00940329 | COMPLETED | Healthy |
AstraZeneca |
2004-04 | PHASE1 |
| NCT00108823 | COMPLETED | Chronic Obstructive Pulmonary Disease, COPD |
AstraZeneca |
2004-10 | PHASE3 |
| NCT00430729 | COMPLETED | Chronic Obstructive Pulmonary Disease; COPD |
AstraZeneca |
2003-01 | PHASE3 |
| NCT00073177 | COMPLETED | Asthma |
AstraZeneca |
2003-11 | PHASE3 |
| NCT00062582 | COMPLETED | Chronic Obstructive Pulmonary Disease; COPD |
AstraZeneca |
2003-06 | PHASE3 |
| NCT00076076 | COMPLETED | Asthma |
AstraZeneca |
2003-12 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-06-05)
Check the
Roflumilast
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.