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Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT05335356 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2025-09-12

Study results available
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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.

Conditions

  • Moderate to Severe Chronic Plaque Psoriasis

Interventions

BIOLOGICAL

Stelara

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 .

BIOLOGICAL

Bmab1200

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

Sponsors & Collaborators

  • Biocon Biologics UK Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2023-01-26
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335356 on ClinicalTrials.gov