Apremilast has been evaluated across numerous clinical trials spanning Phase I through Phase IV, investigating conditions such as plaque psoriasis, juvenile psoriatic arthritis, alopecia areata, chronic hand dermatitis, vitiligo, rheumatoid arthritis, and Behçet syndrome. Featuring recruiting, active not recruiting, completed, and withdrawn recruitment statuses, Phase III trials evaluate treatment efficacy in plaque psoriasis and juvenile psoriatic arthritis. Research is supported by pharmaceutical sponsors like Bristol-Myers Squibb, Amgen, and Takeda, alongside academic centers such as George Washington University and Jinnah Postgraduate Medical Centre.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05767047 | RECRUITING | Behçet's Disease; Juvenile Psoriatic Arthritis |
Amgen |
2023-03-23 | PHASE3 |
| NCT07029529 | RECRUITING | Alcohol Use Disorder |
Yale University |
2026-05-12 | PHASE2 |
| NCT07352566 | NOT_YET_RECRUITING | Psoriasis; Atopic Dermatitis |
University of California, San Francisco |
2026-08-01 | PHASE4 |
| NCT04528082 | RECRUITING | Behçet Disease |
Amgen |
2021-09-09 | PHASE3 |
| NCT05703685 | RECRUITING | Depression |
National Institute of Mental Health (NIMH) |
2023-06-22 | PHASE1 |
| NCT04488081 | ACTIVE_NOT_RECRUITING | COVID-19 |
QuantumLeap Healthcare Collaborative |
2020-07-31 | PHASE2 |
| NCT04804553 | RECRUITING | Active Juvenile Psoriatic Arthritis |
Amgen |
2022-03-17 | PHASE3 |
| NCT07366268 | NOT_YET_RECRUITING | Psoriasis |
Assiut University |
2026-05 | |
| NCT07325266 | RECRUITING | Alcohol Use Disorder; Alcohol Misuse |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
2026-04-03 | PHASE2 |
| NCT07398651 | NOT_YET_RECRUITING | Psoriatic Arthritis; Ultrasound Assessment; TNF |
Tanta University |
2026-12-30 | |
| NCT06593197 | ENROLLING_BY_INVITATION | Vitiligo |
Dow University of Health Sciences |
2025-01-01 | PHASE4 |
| NCT04227314 | RECRUITING | Recurrent Aphtous Stomatitis |
University Hospital, Rouen |
2022-04-10 | PHASE3 |
| NCT07432386 | NOT_YET_RECRUITING | Psoriasis; Pruritus |
Zarmeen Khawar |
2026-05-14 | PHASE4 |
| NCT06324435 | ACTIVE_NOT_RECRUITING | Alcohol Use Disorder |
Yale University |
2024-05-08 | PHASE1 |
| NCT06088199 | COMPLETED | Plaque Psoriasis |
Amgen |
2023-10-24 | PHASE3 |
| NCT07337434 | RECRUITING | Chronic Plaque Psoriasis |
Syeda Sana Zaman |
2025-12-25 | EARLY_PHASE1 |
| NCT06863493 | NOT_YET_RECRUITING | Psoriasis (PsO) |
SFA Therapeutics |
2025-06-01 | PHASE2; PHASE3 |
| NCT07712731 | COMPLETED | Psoriasis |
Newsoara Biopharma Co., Ltd. |
2025-04-18 | PHASE3 |
| NCT02735707 | RECRUITING | Community-acquired Pneumonia, Influenza, COVID-19 |
UMC Utrecht |
2016-04-11 | PHASE3 |
| NCT05565560 | ACTIVE_NOT_RECRUITING | Plaque Psoriasis |
Amgen |
2023-01-25 | PHASE3 |
| NCT05601492 | WITHDRAWN | Psoriasis |
Wake Forest University Health Sciences |
2025-06 | EARLY_PHASE1 |
| NCT04175613 | COMPLETED | Psoriasis |
Amgen |
2019-12-20 | PHASE3 |
| NCT06260904 | COMPLETED | Oral Lichen Planus |
All India Institute of Medical Sciences, Bhubaneswar |
2024-01-26 | PHASE4 |
| NCT06509984 | RECRUITING | Epidermolysis Bullosa Simplex; Genodermatosis |
Centre Hospitalier Universitaire de Nice |
2024-08-06 | PHASE2 |
| NCT06588738 | COMPLETED | Plaque Psoriasis |
Alumis Inc |
2024-08-20 | PHASE3 |
| NCT06586112 | COMPLETED | Plaque Psoriasis |
Alumis Inc |
2024-07-25 | PHASE3 |
| NCT07708480 | COMPLETED | Hidradenitis Suppurativa |
Hayat Abad Medical Complex, Peshawar |
2024-12-22 | PHASE4 |
| NCT06122649 | COMPLETED | Plaque Psoriasis |
Amgen |
2023-11-27 | PHASE3 |
| NCT06088043 | COMPLETED | Plaque Psoriasis |
Takeda |
2023-11-06 | PHASE3 |
| NCT05875714 | COMPLETED | Erythema Multiforme |
Robert Micheletti |
2022-01-13 | PHASE2 |
| NCT06108544 | COMPLETED | Plaque Psoriasis |
Takeda |
2023-11-06 | PHASE3 |
| NCT04610476 | UNKNOWN | Psoriatic Arthritis; Withdrawal; Reduction |
University of Erlangen-Nürnberg Medical School |
2020-10-19 | PHASE3 |
| NCT04908189 | ACTIVE_NOT_RECRUITING | Psoriatic Arthritis |
Bristol-Myers Squibb |
2021-07-15 | PHASE3 |
| NCT06382987 | Recruiting | Plaque Psoriasis |
Bristol-Myers Squibb |
2024-01-22 | -- |
| NCT06122649 | Recruiting | Plaque Psoriasis |
Amgen |
2023-11-27 | Phase 3 |
| NCT06108544 | Recruiting | Plaque Psoriasis |
Takeda |
2023-11-06 | Phase 3 |
| NCT06088043 | Recruiting | Plaque Psoriasis |
Takeda |
2023-11-06 | Phase 3 |
| NCT02144857 | UNKNOWN | Psoriasis |
University of Athens |
2014-05-30 | PHASE4 |
| NCT05174065 | COMPLETED | Palmoplantar Pustulosis |
Amgen |
2022-03-08 | PHASE3 |
| NCT06032858 | COMPLETED | Psoriasis |
Ghurki Trust and Teaching Hospital |
2022-03-06 | PHASE4 |
| NCT05926882 | COMPLETED | Alopecia Areata |
Jinnah Postgraduate Medical Centre |
2022-08-01 | PHASE4 |
| NCT04908475 | COMPLETED | Psoriasis |
AbbVie |
2021-06-09 | PHASE4 |
| NCT06084663 | COMPLETED | Psoriasis and Psoriatic Arthritis |
Humanis Saglık Anonim Sirketi |
2023-02-15 | PHASE3 |
| NCT04645420 | COMPLETED | Psoriatic Arthritis |
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
2020-11-12 | |
| NCT03747939 | COMPLETED | Arthritis, Psoriatic |
Amgen |
2018-12-31 | PHASE4 |
| NCT03656666 | UNKNOWN | Lichen Planus of Vulva; Female Genital Disease |
Oslo University Hospital |
2019-09-24 | PHASE2 |
| NCT05926882 | Completed | Alopecia Areata |
Jinnah Postgraduate Medical Centre |
2022-08-01 | Phase 4 |
| NCT04306965 | COMPLETED | Atopic Dermatitis |
Tufts Medical Center |
2020-08-01 | PHASE2 |
| NCT03701763 | COMPLETED | Psoriasis |
Amgen |
2018-12-19 | PHASE3 |
| NCT04804553 | Recruiting | Active Juvenile Psoriatic Arthritis |
Amgen |
2022-03-17 | Phase 3 |
| NCT04102449 | WITHDRAWN | Psoriatic Arthritis |
Medical University of Graz |
2020-07-01 | PHASE4 |
| NCT03168256 | COMPLETED | Plaque Psoriasis |
Can-Fite BioPharma |
2018-09-15 | PHASE3 |
| NCT03783026 | COMPLETED | Psoriatic Arthritis |
Amgen |
2019-02-06 | PHASE4 |
| NCT03442088 | COMPLETED | Plaque Psoriasis |
University Hospitals Cleveland Medical Center |
2018-06-01 | PHASE2 |
| NCT03777436 | COMPLETED | Psoriasis |
Amgen |
2019-02-11 | PHASE3 |
| NCT03160248 | COMPLETED | Nummular Eczema; Eczema; Dermatitis Eczema; Nummular Dermatitis |
Technical University of Munich |
2017-07-05 | PHASE2 |
| NCT04811573 | TERMINATED | Healthy |
Boehringer Ingelheim |
2021-03-31 | PHASE1 |
| NCT03082729 | COMPLETED | Psoriasis; Cardiovascular Diseases |
University of Pennsylvania |
2017-04-24 | PHASE4 |
| NCT04590586 | COMPLETED | COVID-19 |
Amgen |
2020-11-24 | PHASE3 |
| NCT03690544 | COMPLETED | Recurrent Aphthous Stomatitis |
Mayo Clinic |
2018-10-12 | PHASE4 |
| NCT04555707 | UNKNOWN | Psoriasis |
Derm Research, PLLC |
2020-06-24 | PHASE4 |
| NCT04515732 | UNKNOWN | Psoriasis; Psoriatic Arthritis |
Professor Mikkel Østergaard |
2018-12-14 | PHASE4 |
| NCT03529955 | COMPLETED | Dermatomyositis, Adult Type |
Tulane University |
2018-06-12 | PHASE2 |
| NCT03521687 | COMPLETED | Central Centrifugal Cicatricial Alopecia |
Icahn School of Medicine at Mount Sinai |
2018-11-15 | PHASE4 |
| NCT04161456 | COMPLETED | Acne Conglobata |
Dr. Frank Behrens |
2019-10-09 | PHASE2 |
| NCT03774875 | COMPLETED | Psoriasis |
Amgen |
2019-03-28 | PHASE4 |
| NCT04057937 | COMPLETED | Palmoplantaris Pustulosis |
Amgen |
2019-10-16 | PHASE2 |
| NCT03611751 | COMPLETED | Psoriasis |
Bristol-Myers Squibb |
2018-07-26 | PHASE3 |
| NCT03624127 | COMPLETED | Psoriasis |
Bristol-Myers Squibb |
2018-08-07 | PHASE3 |
| NCT03022617 | COMPLETED | Psoriatic Nail; Psoriasis Vulgaris; Psoriasis |
University of Alabama at Birmingham |
2017-01 | PHASE4 |
| NCT03930186 | COMPLETED | Plaque Psoriasis |
Amgen |
2019-06-17 | PHASE3 |
| NCT03836885 | WITHDRAWN | Oral Lichen Planus |
Sunnybrook Health Sciences Centre |
2019-11-21 | PHASE2 |
| NCT03175549 | COMPLETED | Alcohol Use Disorder |
The Scripps Research Institute |
2017-11-01 | PHASE2 |
| NCT04822909 | COMPLETED | Erythema Nodosum Leprosum |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2019-09-15 | PHASE4 |
| NCT03721172 | COMPLETED | Psoriasis |
Amgen |
2019-03-11 | PHASE3 |
| NCT03453190 | UNKNOWN | Psoriasis |
Washington Dermatology Center |
2018-02-25 | PHASE4 |
| NCT03576287 | UNKNOWN | Prurigo Nodularis |
Tanja Todberg, MD |
2017-07-01 | PHASE1; PHASE2 |
| NCT03553433 | UNKNOWN | Psoriasis of Scalp; Psoriasis Vulgaris |
University of Zurich |
2018-06 | PHASE4 |
| NCT04572997 | COMPLETED | Palmoplantar Pustulosis |
Kristian Reich |
2018-11-29 | PHASE2 |
| NCT03123016 | COMPLETED | Vitiligo |
Icahn School of Medicine at Mount Sinai |
2017-04-14 | PHASE2 |
| NCT03741933 | WITHDRAWN | Chronic Hand Dermatitis |
George Washington University |
2019-02-28 | PHASE4 |
| NCT03191539 | UNKNOWN | Arthritis; Psoriasis (Etiology) |
Hospital Universitari Vall d'Hebron Research Institute |
2017-11-02 | PHASE3 |
| NCT03146247 | WITHDRAWN | Moderate to Severe Plaque Psoriasis |
Diamant Thaci |
2017-10-23 | PHASE4 |
| NCT03422640 | UNKNOWN | Frontal Fibrosing Alopecia |
Bellevue Dermatology |
2018-07-12 | PHASE4 |
| NCT03036995 | COMPLETED | Vitiligo |
Centre Hospitalier Universitaire de Nice |
2017-03-20 | PHASE2 |
| NCT03239106 | COMPLETED | Itch |
Washington University School of Medicine |
2017-12-01 | PHASE2 |
| NCT03441789 | COMPLETED | Plaque Psoriasis |
L.H. Kircik, M.D. |
2017-09-18 | PHASE4 |
| NCT03123471 | COMPLETED | Psoriasis |
Amgen |
2017-05-16 | PHASE3 |
| NCT03000309 | COMPLETED | Plaque Psoriasis |
Derm Research, PLLC |
2016-12-29 | PHASE4 |
| NCT03049267 | COMPLETED | Hidradenitis Suppurativa |
M.B.A. van Doorn |
2017-02-02 | PHASE2 |
| NCT02963779 | COMPLETED | Healthy |
Eli Lilly and Company |
2016-12 | PHASE1 |
| NCT02289417 | COMPLETED | Ulcerative Colitis |
Amgen |
2015-01-08 | PHASE2 |
| NCT02307513 | COMPLETED | Behçet's Syndrome |
Amgen |
2014-12-30 | PHASE3 |
| NCT02684123 | COMPLETED | Alopecia Areata |
Icahn School of Medicine at Mount Sinai |
2016-02 | |
| NCT02576678 | COMPLETED | Psoriasis |
Amgen |
2015-10-13 | PHASE2 |
| NCT02749370 | COMPLETED | Plaque Psoriasis |
Amgen |
2016-05-18 | PHASE4 |
| NCT02695212 | COMPLETED | Hidradenitis Suppurativa |
Florida Academic Dermatology Centers |
2016-07 | PHASE2 |
| NCT02777554 | COMPLETED | Healthy Volunteers |
Amgen |
2016-08-17 | PHASE1 |
| NCT02558361 | WITHDRAWN | Psoriatic Arthritis |
University of South Florida |
2016-04 | PHASE4 |
| NCT02400749 | COMPLETED | Palmo-plantar Psoriasis |
Innovaderm Research Inc. |
2015-05 | PHASE4 |
| NCT02802735 | COMPLETED | Pharmacokinetics |
Amgen |
2016-06-22 | PHASE1 |
| NCT02412644 | COMPLETED | Plaque Psoriasis |
Psoriasis Treatment Center of Central New Jersey |
2015-05-28 | PHASE4 |
| NCT02641353 | COMPLETED | Healthy Volunteers |
Amgen |
2016-01-05 | PHASE1 |
| NCT02425826 | COMPLETED | Parapsoriasis |
Amgen |
2015-04-20 | PHASE4 |
| NCT02087943 | COMPLETED | Dermatitis, Atopic Dermatitis |
Amgen |
2014-06 | PHASE2 |
| NCT01925768 | COMPLETED | Psoriatic Arthritis |
Amgen |
2013-09-04 | PHASE3 |
| NCT01988103 | COMPLETED | Psoriasis; Psoriatic Arthritis; Psoriasis Arthropatica |
Amgen |
2013-07-09 | PHASE2 |
| NCT02236988 | COMPLETED | Healthy Volunteers |
Amgen |
2014-01-07 | PHASE1 |
| NCT01690299 | COMPLETED | Psoriasis; Psoriatic Arthritis |
Amgen |
2012-10-01 | PHASE3 |
| NCT01250548 | COMPLETED | Rheumatoid Arthritis |
Baylor Research Institute |
2010-05 | PHASE2 |
| NCT01583374 | COMPLETED | Ankylosing Spondyloarthritis |
Amgen |
2012-05-02 | PHASE3 |
| NCT01200472 | COMPLETED | Erosive Osteoarthritis of the Hand |
University of Erlangen-Nürnberg Medical School |
2010-08 | PHASE2 |
| NCT01307423 | COMPLETED | Psoriatic Arthritis |
Amgen |
2010-12-09 | PHASE3 |
| NCT01045551 | COMPLETED | Erythematotelangiectatic Rosacea; Papulopustular Rosacea |
Julian M. Mackay-Wiggan |
2010-06 | PHASE2 |
| NCT01212770 | COMPLETED | Psoriatic Arthritis |
Amgen |
2010-09-30 | PHASE3 |
| NCT01212757 | COMPLETED | Psoriatic Arthritis |
Amgen |
2010-09-27 | PHASE3 |
| NCT00866359 | COMPLETED | Behcet Syndrome |
Amgen |
2009-08-01 | PHASE2 |
| NCT01172938 | COMPLETED | Psoriatic Arthritis |
Amgen |
2010-06-02 | PHASE3 |
| NCT01561963 | COMPLETED | Healthy Subjects |
Amgen |
2012-02-01 | PHASE1 |
| NCT01232283 | COMPLETED | Plaque Psoriasis |
Amgen |
2010-11-22 | PHASE3 |
| NCT01634191 | COMPLETED | Healthy Volunteer |
Amgen |
2012-02-01 | PHASE1 |
| NCT01634178 | COMPLETED | Healthy Volunteer |
Amgen |
2012-02-01 | PHASE1 |
| NCT01194219 | COMPLETED | Plaque Psoriasis |
Amgen |
2010-09-09 | PHASE3 |
| NCT01285310 | TERMINATED | Rheumatoid Arthritis |
Amgen |
2010-12-09 | PHASE2 |
| NCT01041625 | UNKNOWN | Lichen Planus |
Virginia Clinical Research, Inc. |
2010-02 | PHASE2 |
| NCT01200264 | WITHDRAWN | Chronic Plaque Psoriasis |
Duke University |
2010-09 | PHASE2 |
| NCT01204138 | WITHDRAWN | Arthritis, Rheumatoid |
Stanford University |
2010-09 | PHASE2 |
| NCT01140503 | TERMINATED | Dermatomyositis |
Stanford University |
2010-02 | |
| NCT01393158 | COMPLETED | Atopic Dermatitis |
Oregon Health and Science University |
2009-05 | PHASE2 |
| NCT00889421 | TERMINATED | Uveitis |
Oregon Health and Science University |
2009-11 | PHASE1; PHASE2 |
| NCT00944658 | COMPLETED | Ankylosing Spondylitis |
Imperial College London |
2009-08 | PHASE2 |
| NCT00997581 | WITHDRAWN | Acute Gout |
Dartmouth-Hitchcock Medical Center |
2010-04 | PHASE2 |
| NCT01074502 | TERMINATED | Acne |
University of North Carolina, Chapel Hill |
2010-02 | PHASE2 |
| NCT00931242 | COMPLETED | Atopic Dermatitis; Allergic Contact Dermatitis |
Tufts Medical Center |
2009-06 | PHASE2 |
| NCT00773734 | COMPLETED | Psoriasis; Plaque-type Psoriasis |
Amgen |
2008-09-01 | PHASE2 |
| NCT00456092 | COMPLETED | Psoriatic Arthritis |
Amgen |
2007-03-05 | PHASE2 |
| NCT00521339 | COMPLETED | Psoriasis-Type Psoriasis; Plaque-Type Psoriasis |
Amgen |
2007-08-01 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-12-01)
Check the
Apremilast
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.