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Monoclonal Antibodies

Bmab1200 vs Stelara for Plaque Psoriasis (STELLAR-2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Biocon Biologics UK Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion)
Patient with moderate to severe chronic plaque psoriasis as defined by BSA (Body surface area) involvement 10%, PASI score ≥12, and sPGA ≥3 at the screening and baseline visits
Must not have
Patient meeting any of the following tuberculosis (TB)-related conditions
Have a transplanted organ/tissue or stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 28 and 52
Awards & highlights

Summary

This trial compares two medications, Bmab 1200 and Stelara, for treating moderate to severe chronic plaque psoriasis in adults. These patients need more intensive treatments. The medications work by targeting the immune system to reduce inflammation and slow down skin cell growth. Stelara is used for treating moderate to severe plaque psoriasis.

Who is the study for?
Adults aged 18-80 with moderate to severe chronic plaque psoriasis, stable for at least 2 months, and candidates for systemic therapy or phototherapy. They must have a BSA involvement of ≥10%, PASI score ≥12, sPGA ≥3, weigh <130 kg, and have good kidney and liver function. Women must not be pregnant and all participants should agree to use contraception.
What is being tested?
The study is testing the effectiveness and safety of two drugs: Bmab1200 versus Stelara in adults with chronic plaque psoriasis. It's a randomized (patients are assigned by chance), double-blind (neither patients nor researchers know who gets which treatment), active-controlled (comparing against an existing treatment) trial across multiple centers.
What are the potential side effects?
While specific side effects aren't listed here, both Bmab1200 and Stelara can potentially cause immune system-related issues due to their nature as immunomodulatory therapies. This may include increased risk of infections or reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disease has not worsened in the last 2 months.
Select...
I have severe psoriasis covering more than 10% of my body.
Select...
I am a woman who can have children and have tested negative for pregnancy.
Select...
I am between 18 and 80 years old and weigh less than 130 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition related to tuberculosis.
Select...
I have had an organ, tissue, or stem cell transplant.
Select...
I have not used, nor plan to use, any treatments that could worsen my psoriasis.
Select...
I have had a serious fungal or mycobacterial infection.
Select...
I have been treated with more than one biologic for psoriasis or psoriatic arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 28 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 28 and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Psoriasis Area and Severity Index (PASI)
Secondary study objectives
Affected body surface area
Dermatology Life Quality Index scores
PASI improvement
+2 more
Other study objectives
Developing neutralizing antibodies
Immunogenicity:-Developing antidrug antibodies
Pharmacokinetic:-Serum concentrations
+2 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172
50%
Upper respiratory infection
27%
Common cold
9%
Fracture
9%
Skin and subcutaneous tissue disorders
9%
Anxiety
9%
Dizziness
9%
Back pain
9%
Urinary tract infection
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Toothache
5%
Pain/Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bmab1200Experimental Treatment1 Intervention
Bmab 1200 45 mg Bmab 1200 90 mg
Group II: StelaraActive Control1 Intervention
Stelara 45 mg Stelara 90 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bmab1200
2022
Completed Phase 3
~390

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Plaque Psoriasis treatments often involve biologic agents that target specific components of the immune system to reduce inflammation and slow the overproduction of skin cells. Ustekinumab and similar agents like Bmab 1200 target interleukin-12 (IL-12) and interleukin-23 (IL-23), which are cytokines involved in the inflammatory pathways that contribute to psoriasis. By inhibiting these cytokines, these treatments can effectively reduce the severity of psoriasis symptoms. This is crucial for patients as it not only improves skin appearance but also reduces the risk of comorbid conditions such as cardiovascular disease, which is linked to chronic inflammation in psoriasis.
Biologics in the management of psoriasis.

Find a Location

Who is running the clinical trial?

Biocon Biologics UK LtdLead Sponsor
3 Previous Clinical Trials
1,052 Total Patients Enrolled

Media Library

Plaque Psoriasis Research Study Groups: Bmab1200, Stelara
Plaque Psoriasis Clinical Trial 2023: Bmab1200 Highlights & Side Effects. Trial Name: NCT05335356 — Phase 3
~121 spots leftby Sep 2025
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