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ClinicalTrials.gov public records Last synced Oct 30, 2026, 10:24 AM EDT

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Showing 1–24 of 60 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: roflumilast Clear all
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 Oct 8, 2026 · Synced Oct 30, 2026, 10:24 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 19, 2018 · Synced Oct 30, 2026, 10:24 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 8, 2025 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 3 Interventional Results available

Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04286607
View directory record Official record
Conditions
Chronic Plaque Psoriasis
Interventions
Topical roflumilast
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years to 11 Years
Enrollment
337 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
68
States / cities
Scottsdale, Arizona • Beverly Hills, California • Encinitas, California + 58 more
Source: ClinicalTrials.gov public record
Updated Sep 9, 2026 · Synced Oct 30, 2026, 10:24 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 23, 2025 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

NCT04773600
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
Roflumilast Cream, Vehicle cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
6 Years and older
Enrollment
683 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
44
States / cities
Birmingham, Alabama • Fort Smith, Arkansas • Inglewood, California + 38 more
Source: ClinicalTrials.gov public record
Updated Oct 4, 2024 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

NCT02097992
View directory record Official record
Conditions
COPD
Interventions
Roflumilast Placebo, Roflumilast
Drug
Lead sponsor
University of Miami
Other
Eligibility
45 Years and older
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 24, 2017 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 3 Interventional Results available

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

NCT04845620
View directory record Official record
Conditions
Atopic Dermatitis Eczema
Interventions
Roflumilast Cream 0.05%, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
2 Years to 5 Years
Enrollment
652 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
71
States / cities
Birmingham, Alabama • Montgomery, Alabama • Gilbert, Arizona + 60 more
Source: ClinicalTrials.gov public record
Updated Dec 23, 2025 · Synced Oct 30, 2026, 10:24 AM EDT
Recruiting Early Phase 1 Interventional Accepts healthy volunteers

Exercise as an Immune Adjuvant for Allogeneic Cell Therapies

NCT06643221
View directory record Official record
Conditions
Leukemia, Hematopoetic Stem Cell Transplantation, Donor Lymphocyte Infusion, CAR T-Cell Therapy, Lymphoma, Cell Therapy
Interventions
Exercise, Isoproterenol, Placebo, Bisoprolol Fumarate Tablet 10 mg, Nadolol (1 x 80 mg) Tablets (Invamed, Inc), Carvedilol 50 mg, Roflumilast 500 Mcg Oral Tablet
Behavioral · Drug
Lead sponsor
University of Arizona
Other
Eligibility
21 Years to 55 Years
Enrollment
200 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2031
U.S. locations
1
States / cities
Tucson, Arizona
Source: ClinicalTrials.gov public record
Updated Jun 5, 2026 · Synced Oct 30, 2026, 10:24 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 19, 2020 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 3 Interventional

Roflumilast or Azithromycin to Prevent COPD Exacerbations Trial

NCT04069312
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease Severe, Chronic Bronchitis
Interventions
Roflumilast, Azithromycin
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
40 Years and older
Enrollment
1,032 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
28
States / cities
Birmingham, Alabama • Tucson, Arizona • Sacramento, California + 23 more
Source: ClinicalTrials.gov public record
Updated Aug 21, 2026 · Synced Oct 30, 2026, 10:24 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 2, 2026 · Synced Oct 30, 2026, 10:24 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 2, 2022 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Not applicable Interventional Results available

A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)

NCT01572948
View directory record Official record
Conditions
COPD
Interventions
roflumilast, placebo
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
40 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Oct 19, 2015 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers

Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

NCT05278624
View directory record Official record
Conditions
Rosacea
Interventions
Roflumilast Cream
Drug
Lead sponsor
Dermatology Consulting Services, PLLC
Network
Eligibility
18 Years to 70 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
High Point, North Carolina
Source: ClinicalTrials.gov public record
Updated May 31, 2023 · Synced Oct 30, 2026, 10:24 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 29, 2024 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 3 Interventional Results available

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

NCT00297115
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
1,568 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
151
States / cities
Bayou La Batre, Alabama • Birmingham, Alabama • Huntsville, Alabama + 131 more
Source: ClinicalTrials.gov public record
Updated Nov 7, 2016 · Synced Oct 30, 2026, 10:24 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 26, 2022 · Synced Oct 30, 2026, 10:24 AM EDT
Recruiting Phase 4 Interventional

Obtaining Descriptive Classifications of Pruritus and Assessing Change in Pruritus Over Time in Atopic Dermatitis Patients Using Topical Roflumilast Cream.

NCT07560618
View directory record Official record
Conditions
ITCH, Atopic Dermatitis
Interventions
Roflumilast Cream 0.15%
Drug
Lead sponsor
Integrative Skin Science and Research
Industry
Eligibility
12 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Oct 30, 2026, 10:24 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 16, 2017 · Synced Oct 30, 2026, 10:24 AM EDT
Not listed Phase 4 Interventional

Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

NCT01830959
View directory record Official record
Conditions
Sarcoidosis
Interventions
Roflumilast, Placebo
Drug
Lead sponsor
University of Cincinnati
Other
Eligibility
18 Years to 70 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 8, 2015 · Synced Oct 30, 2026, 10:24 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 9, 2024 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 2 Interventional Results available

The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

NCT03638258
View directory record Official record
Conditions
Plaque Psoriasis
Interventions
Roflumilast Cream 0.3%, Roflumilast Cream 0.15%, Vehicle Cream
Drug
Lead sponsor
Arcutis Biotherapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
331 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
20
States / cities
Beverly Hills, California • Northridge, California • San Diego, California + 16 more
Source: ClinicalTrials.gov public record
Updated Sep 2, 2022 · Synced Oct 30, 2026, 10:24 AM EDT
Completed Phase 2 Interventional

A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa

NCT07077902
View directory record Official record
Conditions
Hidradenitis Suppurativa
Interventions
Topical roflumilast 0.3% foam
Drug
Lead sponsor
Tulane University
Other
Eligibility
18 Years to 90 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
4
States / cities
Covington, Louisiana • New Orleans, Louisiana
Source: ClinicalTrials.gov public record
Updated Oct 9, 2026 · Synced Oct 30, 2026, 10:24 AM EDT