CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 384 enrolled
Drug / intervention
Stelara +1 morebiological
Likely dose
Stelara 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05335356
NCT05335356Phase 3Completed
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A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

Biocon Biologics UK Ltd·interventional·Posted Apr 19, 2022·Updated Sep 12, 2025

In Brief

A Phase 3 clinical trial evaluating Stelara and Bmab1200 for Moderate to Severe Chronic Plaque Psoriasis. Completed, enrolled 384 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate to Severe Chronic Plaque Psoriasis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedApr 19, 2022
Enrollment StartJun 28, 2022
Primary CompletionJan 26, 2023
Study CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.2 years ago

Interventions

Stelarabiological

45 mg , 90 mg at Week 0, 4, 16, 28 and 40;During the study after receiving 2 doses , before dosing at Week 16 patients were re-randomised in a 1:1 ratio to receive either Bmab 1200 or Stelara .

Bmab1200biological

45 mg , 90 mg at Week 0, 4, 16, 28 and 40