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NCT02742441
A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 310)
Phase 3 trial testing 122-0551 Foam in Plaque Psoriasis in 409 participants. Completed in 16 June 2017.
27 February 2017
Quick facts
| Lead sponsor | Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 409 |
| Start date | 1 June 2016 |
| Primary completion | 27 February 2017 |
| Estimated completion | 16 June 2017 |
| Sites | 21 locations across United States |
Drugs / interventions tested
- 122-0551 Foam — full drug profile →
- Vehicle Foam — 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.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
Time frame: Day 15
The IGA score is a static evaluation of the overall or "average" degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling,
Sponsor's own description
This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis
Bhatia N, Stein Gold L, Kircik LH, Schreiber R. · · 2019 · cited 2× · PMID 31424709
Verify or expand the search:
- PubMed search for NCT02742441
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT04080206 — A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis · Phase 2 · 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
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 NCT02742441 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 21 May 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 Therapeutics, Inc.
- Last refreshed: 16 October 2018
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/NCT02742441.