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NCT04549870: PSORRO
Efficacy of Roflumilast in the Treatment of Psoriasis
Phase 2 trial testing Roflumilast in Psoriasis in 46 participants. Completed in 12 December 2022.
12 December 2022
Quick facts
| Lead sponsor | Bispebjerg Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 January 2021 |
| Primary completion | 12 December 2022 |
| Estimated completion | 12 December 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Roflumilast (ROFLUMILAST) — full drug profile →
Conditions studied
- Psoriasis — all drugs for Psoriasis →
Sponsor
Bispebjerg Hospital
Who can join
Adults 18 to 90, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Roflumilast (Daxas®), a selective, long-acting inhibitor of the enzyme phosphodiesterase-4 (PDE4), is used for severe chronic obstructive pulmonary disease. Recent research suggest roflumilast is effective in treating psoriasis. The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis. This has not previously been done.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Clinical Implication of Phosphodiesterase-4-Inhibition.
Schick MA, Schlegel N. · · 2022 · cited 56× · PMID 35163131 · DOI 10.3390/ijms23031209 -
Phosphodiesterase-4 Inhibition in Psoriasis.
Milakovic M, Gooderham MJ. · · 2021 · cited 54× · PMID 33763335 · DOI 10.2147/ptt.s303634 -
Key Signaling Pathways in Psoriasis: Recent Insights from Antipsoriatic Therapeutics.
Ben Abdallah H, Johansen C, Johansen C, Iversen L. · · 2021 · cited 48× · PMID 34235053 · DOI 10.2147/ptt.s294173 -
Efficacy and safety of oral roflumilast for moderate-to-severe psoriasis-a randomized controlled trial (PSORRO).
Gyldenløve M, Meteran H, Sørensen JA, Fage S, et al · · 2023 · cited 25× · PMID 37465323 · DOI 10.1016/j.lanepe.2023.100639 -
Phosphodiesterase-4 Inhibition in the Management of Psoriasis.
Crowley EL, Gooderham MJ. · · 2023 · cited 24× · PMID 38258034 · DOI 10.3390/pharmaceutics16010023 -
Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology.
Carmona-Rocha E, Rusiñol L, Puig L. · · 2025 · cited 11× · PMID 39861739 · DOI 10.3390/pharmaceutics17010091 -
Oral Roflumilast Suppresses Proinflammatory Cytokine Signaling and Reduces CD4+ T-Cell and Neutrophil Infiltration in Psoriasis.
Baez E, Gyldenløve M, Ben Abdallah H, Emmanuel T, et al · · 2025 · cited 1× · PMID 40403838 · DOI 10.1016/j.jid.2025.04.034
Verify or expand the search:
- PubMed search for NCT04549870
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07174011 — Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the T · Phase 4 · completed
- NCT06440473 — Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin · Phase 4 · recruiting
Other recruiting trials for Psoriasis
Currently open trials in the same condition.
- NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
- NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
- NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
- NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
- NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting
Other Bispebjerg Hospital trials
Trials by the same sponsor.
- NCT06872060 — The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance. · NA · not yet recruiting
- NCT07373587 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy · NA · not yet recruiting
- NCT07123558 — Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men · NA · not yet recruiting
- NCT07124338 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibili · NA · active not recruiting
- NCT07096648 — Alert Burden When Monitoring Patients at Home · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04549870 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bispebjerg Hospital
- Last refreshed: 28 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04549870.
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