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NCT03421197 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)
A Phase 2 study of Psoriasis, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 426
- Enrollment target
- 20
- Study locations
NCT03421197 is a Phase 2 study of Psoriasis that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 426 participants, below the 485-participant average among 125 other Psoriasis trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT03421197, a Phase 2 study of Psoriasis, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 426 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PPC-06 400 mg QD
- DRUG PPC-06 400 mg BID
- DRUG PPC-06 600 mg
Study Locations (20)
California
- Site 133 - Fountain Valley
- Site 107 - Fremont
- Site 121 - Fresno
- Site 153 - Fullerton
- Site 176 - Los Angeles
- Site 178 - Los Angeles
- Site 182 - Los Angeles
- Site 156 - Murrieta
- Site 141 - San Diego
- Site 155 - Santa Rosa
Arizona
- Site 144 - Glendale
- Site 167 - Phoenix
- Site 158 - Phoenix
- Site 170 - Tempe
Florida
- Site 137 - Clearwater
- Site 130 - Coral Gables
- Site 143 - Hialeah
- Site 145 - Hialeah
Arkansas
- Site 157 - Bryant
- Site 125 - Rogers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2018-01-25 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03421197
The ClinicalTrials.gov registry entry for NCT03421197 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 426 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 485-participant average among 125 other Psoriasis trials with a reported enrollment target (12% lower). The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03421197 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03421197 about?
NCT03421197 is a clinical study titled "A Study to Assess the Efficacy and Safety of PPC-06 (Tepilamide Fumarate)". This is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of PPC-06 (tepilamide fumarate) extended release in subjects with moderate-to-severe plaque psoriasis.
What is the current status of trial NCT03421197?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 426 participants. The study started on 2018-01-25. Estimated completion is 2020-03-30.
What conditions does trial NCT03421197 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT03421197?
The interventions under investigation include: Placebo (DRUG), PPC-06 400 mg QD (DRUG), PPC-06 400 mg BID (DRUG), PPC-06 600 mg (DRUG).
Who is sponsoring clinical trial NCT03421197?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03421197 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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