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NCT01483924
A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Phase 2 trial testing Apo805K1 in Plaque Psoriasis in 60 participants. Completed in 1 October 2013.
1 August 2013
Quick facts
| Lead sponsor | ApoPharma |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 November 2011 |
| Primary completion | 1 August 2013 |
| Estimated completion | 1 October 2013 |
| Sites | 7 locations across United States, Canada |
Drugs / interventions tested
- Apo805K1 — full drug profile →
Conditions studied
- Plaque Psoriasis — all drugs for Plaque Psoriasis →
Sponsor
ApoPharma — full company profile →
Who can join
Adults 18 to 65, 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.
-
Number of Patients With Adverse Events
Time frame: 12 Weeks
The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.
Sponsor's own description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in 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 NCT01483924
- 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 ApoPharma trials
Trials by the same sponsor.
- NCT03802916 — Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload · Phase 2 · completed
- NCT02728843 — Study of Parkinson's Early Stage With Deferiprone · Phase 2 · completed
- NCT02443545 — Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias · Phase 4 · terminated
- NCT02041299 — Efficacy and Safety of Ferriprox® in Patients With Sickle Cell Disease or Other Anemias · Phase 4 · terminated
- NCT01741532 — Efficacy and Safety Study of Deferiprone in Patients With Pantothenate Kinase-associated Neurodegeneration (PKAN) · 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 NCT01483924 (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 ApoPharma
- Last refreshed: 9 February 2015
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/NCT01483924.
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