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Showing 1–24 of 60 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: roflumilast Clear all
Recruiting Phase 2 Interventional

The Safety and Efficacy of Roflumilast Foam in HS

NCT07263230
View directory record Official record
Conditions
Hidradenitis Suppurativa (HS)
Interventions
Roflumilast 0.3% topical foam
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 8, 2026 · Synced Sep 7, 2026, 5:27 AM EDT
Recruiting Phase 1 Interventional

Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

NCT06977711
View directory record Official record
Conditions
Diffuse Large B-cell Lymphoma
Interventions
Loncastuximab, Roflumilast, Rituximab, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
2
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 2 Interventional

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

NCT06998056
View directory record Official record
Conditions
Atopic Dermatitis (Eczema)
Interventions
ARQ-151 cream 0.05%
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
3 Months to 2 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
17
States / cities
Birmingham, Alabama • Bryant, Arkansas • Fountain Valley, California + 14 more
Source: ClinicalTrials.gov public record
Updated Dec 9, 2025 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 1Phase 2 Interventional Results available

PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of McCune-Albright Syndrome

NCT02743377
View directory record Official record
Conditions
Nervous System Disease
Interventions
Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram, Whole Body PET Blocked with Roflumilast
Other · Drug
Lead sponsor
National Institute of Mental Health (NIMH)
NIH
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 18, 2020 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 1 Interventional

The Role of Phosphodiesterase Inhibitors in Incretin Secretion

NCT02363335
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Placebo, Roflumilast/Sitagliptin, Sitagliptin, Roflumilast
Other
Lead sponsor
National Institute on Aging (NIA)
NIH
Eligibility
21 Years to 55 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 27, 2026 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 3 Interventional Results available

Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04211389
View directory record Official record
Conditions
Chronic Plaque Psoriasis
Interventions
ARQ-151 0.3% cream, ARQ-151 vehicle cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years and older
Enrollment
442 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
31
States / cities
Scottsdale, Arizona • Beverly Hills, California • Encino, California + 26 more
Source: ClinicalTrials.gov public record
Updated Dec 6, 2022 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

NCT04773587
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
Roflumilast Cream 0.15%, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
6 Years and older
Enrollment
654 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
42
States / cities
Montgomery, Alabama • Scottsdale, Arizona • Little Rock, Arkansas + 37 more
Source: ClinicalTrials.gov public record
Updated Oct 8, 2024 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 3 Interventional

The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)

NCT00108823
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease, COPD
Interventions
Roflumilast
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
40 Years and older
Enrollment
550 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
10
States / cities
Cities in California, California • Cities in Colorado, Colorado • Cities in Florida, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 25, 2016 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 4 Interventional Results available

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

NCT01443845
View directory record Official record
Conditions
COPD, COPD Exacerbation, Lung Diseases, Respiratory Disorders, Pulmonary Disease, Chronic Obstructive Lung Diseases, Chronic Obstructive Airway Disease
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
40 Years and older
Enrollment
2,354 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2016
U.S. locations
217
States / cities
Anniston, Alabama • Athens, Alabama • Florence, Alabama + 175 more
Source: ClinicalTrials.gov public record
Updated Apr 12, 2017 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 3 Interventional Results available

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

NCT00297102
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
40 Years and older
Enrollment
1,523 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
47
States / cities
Fullerton, California • Los Angeles, California • Palmdale, California + 43 more
Source: ClinicalTrials.gov public record
Updated Jan 15, 2017 · Synced Sep 7, 2026, 5:27 AM EDT
Terminated Phase 2 Interventional Results available

Safety and Efficacy of Roflumilast and Pioglitazone in Treating Adults With Nonalcoholic SteatoHepatitis

NCT01703260
View directory record Official record
Conditions
Nonalcoholic Steatohapatitis
Interventions
Roflumilast, Pioglitazone, Placebo
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 80 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
4
States / cities
Coronado, California • Annapolis, Maryland • Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jan 31, 2017 · Synced Sep 7, 2026, 5:27 AM EDT
Not yet recruiting Phase 2 Interventional

Safety and Efficacy of Roflumilast Foam 0.3% in Adolescent and Adult Subjects With Hidradenitis Suppurativa

NCT07689188
View directory record Official record
Conditions
Hidradenitis Suppurativa (HS)
Interventions
Roflumilast 0.3% topical foam
Drug
Lead sponsor
Harrison Dermatology
Other
Eligibility
12 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Missouri City, Texas
Source: ClinicalTrials.gov public record
Updated Jul 8, 2026 · Synced Sep 7, 2026, 5:27 AM EDT
Withdrawn Phase 1 Interventional

Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy

NCT05796271
View directory record Official record
Conditions
Lymphoma, B-Cell
Interventions
R-Chop and Roflumilast
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
18 Years to 99 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 28, 2024 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

NCT04091646
View directory record Official record
Conditions
Seborrheic Dermatitis
Interventions
Roflumilast Foam 0.3%, Vehicle foam
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
226 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
22
States / cities
Fremont, California • Santa Monica, California • Coral Gables, Florida + 19 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2023 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 3 Interventional Results available

Enhancement of Corticosteroid Efficacy in COPD

NCT02340520
View directory record Official record
Conditions
COPD
Interventions
Theophylline, Roflumilast
Drug
Lead sponsor
UConn Health
Other
Eligibility
45 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Farmington, Connecticut
Source: ClinicalTrials.gov public record
Updated Jun 18, 2018 · Synced Sep 7, 2026, 5:27 AM EDT
Terminated Phase 1 Interventional Accepts healthy volunteers

Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

NCT04108377
View directory record Official record
Conditions
Asthma
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
University of California, Davis
Other
Eligibility
18 Years and older
Enrollment
5 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2023
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Oct 23, 2023 · Synced Sep 7, 2026, 5:27 AM EDT
Recruiting Phase 2 Interventional

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)

NCT07105254
View directory record Official record
Conditions
Non-segmental Vitiligo
Interventions
Roflumilast topical 0.3% foam
Drug
Lead sponsor
Derm Texas, PLLC
Network
Eligibility
2 Years to 18 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Aug 7, 2025 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 1 Interventional Results available

Roflumilast Plus Alogliptin Proof-of-Mechanism Study in Type2 Diabetes

NCT01664624
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Roflumilast, Alogliptin, Exenatide, Placebo to roflumilast, Placebo to alogliptin
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 80 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012
U.S. locations
2
States / cities
Chula Vista, California • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Jan 31, 2017 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 3 Interventional Results available

Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

NCT01973998
View directory record Official record
Conditions
COPD
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
Temple University
Other
Eligibility
40 Years to 80 Years
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 11, 2020 · Synced Sep 7, 2026, 5:27 AM EDT
Terminated Phase 3 Interventional

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)

NCT04636814
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
CHF6001 1600µg, CHF6001 3200µg, Placebo, Roflumilast
Drug
Lead sponsor
Chiesi Farmaceutici S.p.A.
Industry
Eligibility
40 Years and older
Enrollment
3,973 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
150
States / cities
Andalusia, Alabama • Foley, Alabama • Guntersville, Alabama + 102 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2026 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 2 Interventional Results available

Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

NCT03764475
View directory record Official record
Conditions
Plaque Psoriasis
Interventions
Roflumilast
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
332 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
20
States / cities
Beverly Hills, California • Northridge, California • San Diego, California + 16 more
Source: ClinicalTrials.gov public record
Updated Sep 1, 2022 · Synced Sep 7, 2026, 5:27 AM EDT
Active, not recruiting Phase 2 Interventional

Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge

NCT05418049
View directory record Official record
Conditions
Fragile X Syndrome
Interventions
Baclofen, Memantine, Roflumilast, Placebo
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
18 Years to 45 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 22, 2025 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 3 Interventional

Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

NCT00073177
View directory record Official record
Conditions
Asthma
Interventions
Roflumilast
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 70 Years
Enrollment
819 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2003
U.S. locations
37
States / cities
Cities in Alabama, Alabama • Cities in Arizona, Arizona • Cities in Arkansas, Arkansas + 34 more
Source: ClinicalTrials.gov public record
Updated Oct 24, 2016 · Synced Sep 7, 2026, 5:27 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis

NCT04128007
View directory record Official record
Conditions
Plaque Psoriasis
Interventions
Roflumilast foam 0.3%, Vehicle foam
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
12 Years and older
Enrollment
304 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
31
States / cities
Rogers, Arkansas • Fremont, California • San Diego, California + 27 more
Source: ClinicalTrials.gov public record
Updated Oct 25, 2022 · Synced Sep 7, 2026, 5:27 AM EDT