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NCT02949388
A Randomized, Double Blind, Parallel Group, Placebo-controlled Trial to Study the Efficacy and Safety of Two Oral Doses of Prurisol Administered Twice Daily for Twelve Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis
Phase 2 trial testing Placebo in Chronic Stable Plaque Psoriasis in 199 participants. Completed in 1 December 2017.
1 November 2017
Quick facts
| Lead sponsor | Innovation Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 199 |
| Start date | 1 November 2016 |
| Primary completion | 1 November 2017 |
| Estimated completion | 1 December 2017 |
| Sites | 34 locations across United States |
Drugs / interventions tested
- Placebo
- 400 mg (200 mg BID) — full drug profile →
- 300 mg (150 mg BID) — full drug profile →
Conditions studied
- Chronic Stable Plaque Psoriasis — all drugs for Chronic Stable Plaque Psoriasis →
Sponsor
Innovation Pharmaceuticals, Inc. — full company profile →
Who can join
18 and older, any sex, with Chronic Stable 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.
-
Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12
Time frame: 12 Weeks
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease). -
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 16 Weeks
Reporting of Adverse Events measurements, and reporting of adverse events.
Sponsor's own description
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic 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 NCT02949388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Innovation Pharmaceuticals, Inc. trials
Trials by the same sponsor.
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- NCT03042702 — A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer · Phase 2 · completed
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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 NCT02949388 (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 Innovation Pharmaceuticals, Inc.
- Last refreshed: 9 February 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/NCT02949388.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing