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NCT04080206
A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis
Phase 2 trial testing 188-0551 Spray in Plaque Psoriasis in 55 participants. Completed in 20 January 2021.
20 January 2021
Quick facts
| Lead sponsor | Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 7 April 2020 |
| Primary completion | 20 January 2021 |
| Estimated completion | 20 January 2021 |
| Sites | 8 locations across Georgia, United States, Ukraine |
Drugs / interventions tested
- 188-0551 Spray — full drug profile →
- RLD — full drug profile →
Conditions studied
- Plaque Psoriasis — all drugs for Plaque Psoriasis →
Sponsor
Therapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Plaque Psoriasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" \[RLD\]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04080206
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 188-0551 Spray
Trials testing the same drug.
- NCT03759197 — A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis · Phase 3 · completed
- NCT03731052 — Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307) · Phase 3 · completed
Other recruiting trials for Plaque Psoriasis
Currently open trials in the same condition.
- NCT07357831 — A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psor · Phase 3 · recruiting
- NCT07250802 — A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis · Phase 3 · recruiting
- NCT06979453 — A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants Wit · Phase 3 · recruiting
- NCT07234591 — A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis · NA · recruiting
- NCT07116967 — Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) · Phase 3 · recruiting
Other Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT05363449 — Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis · Phase 1 · completed
- NCT04243486 — A Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis · Phase 2 · completed
- NCT03897257 — A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis · Phase 2 · completed
- NCT03759197 — A Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis · Phase 3 · completed
- NCT03731052 — Comparison of 188-0551 Spray Versus Vehicle Spray in Subjects With Plaque Psoriasis (307) · Phase 3 · completed
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 NCT04080206 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Therapeutics, Inc.
- Last refreshed: 10 May 2021
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/NCT04080206.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing