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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: Completed Phase 2 study of Psoriasis, sponsored by Dr. Reddy's Laboratories Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index (PASI-75) The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.
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 |
What the finished NCT03421197 record still lists
NCT03421197 is an interventional study that assigns participants to a tested intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap, below the 485-participant average among 125 other Psoriasis trials with a reported enrollment target (12% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Psoriasis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03421197's enrollment target sits among peer trials
426 21st of 125 higher than 105 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study in Participants With Moderate to Severe Psoriasis
COMPLETED · Phase 2
-
Study to Evaluate the Efficacy and Safety of JTE-451 in Subjects With Moderate to Severe Plaque Psoriasis
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Etanercept With Tacrolimus for Psoriasis
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A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
COMPLETED · Phase 2
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A Study of R3421 in Patients With Moderate to Severe Chronic Plaque Psoriasis.
COMPLETED · Phase 2
-
Randomized Study of PH-10 for Psoriasis
COMPLETED · Phase 2
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