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NCT05335356 · ClinicalTrials.gov registry record · Phase 3
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study of Moderate-to-severe Chronic Plaque Psoriasis, sponsored by Biocon Biologics UK.
- Completed
- Registry status
- Phase 3
- Development phase
- 384
- Enrollment target
- 1
- Study location
NCT05335356: Completed Phase 3 study of Moderate-to-severe Chronic Plaque Psoriasis, sponsored by Biocon Biologics UK.
NCT05335356 is a Phase 3 study of Moderate-to-severe Chronic Plaque Psoriasis that has completed, run by Biocon Biologics UK. The registered enrollment target is 384 participants, above the 100-participant average among 3 other Moderate-to-severe Chronic Plaque Psoriasis trials with a reported enrollment target (284% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05335356, a Phase 3 study of Moderate-to-severe Chronic Plaque Psoriasis, has completed, sponsored by Biocon Biologics UK.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 384 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.
Primary Outcome
Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12
Conditions Studied
Interventions
- BIOLOGICAL Stelara
- BIOLOGICAL Bmab1200
Study Locations (1)
Ohio
- Apex Clinical Research Center - Mayfield Heights
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2023-11-15 |
| Phase | Phase 3 |
What the finished NCT05335356 record still lists
NCT05335356 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, above the 100-participant average among 3 other Moderate-to-severe Chronic Plaque Psoriasis trials with a reported enrollment target (284% higher).
The record links to 1 condition, with Moderate-to-severe Chronic Plaque Psoriasis appearing as the primary indexed condition, and to 2 interventions - of which Stelara is the first listed.
NCT05335356 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05335356 about?
NCT05335356 is a clinical study titled "Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis". This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.
What is the current status of trial NCT05335356?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 384 participants. The study started on 2022-06-28. Estimated completion is 2023-11-15.
What conditions does trial NCT05335356 study?
This clinical trial studies the following conditions: Moderate-to-severe Chronic Plaque Psoriasis.
What interventions are being tested in trial NCT05335356?
The interventions under investigation include: Stelara (BIOLOGICAL), Bmab1200 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05335356?
This trial is sponsored by Biocon Biologics UK, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05335356 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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