Bmab1200 vs Stelara for Plaque Psoriasis

(STELLAR-2 Trial)

Overseen By Sivakumar Vaidyanathan, M Pharm

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Biocon Biologics UK Ltd

Must not be taking: Biologics, Live vaccines

Disqualifiers: Nonplaque psoriasis, HIV, Hepatitis, TB, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, Bmab1200, to evaluate its effectiveness and safety compared to Stelara for individuals with moderate to severe plaque psoriasis. Plaque psoriasis causes red, scaly patches on the skin, and the trial aims to determine if Bmab1200 can reduce these symptoms. Individuals with chronic plaque psoriasis for at least six months, experiencing moderate to severe symptoms that affect daily life, may be suitable for this trial. Participants will receive either Bmab1200 or Stelara, and researchers will monitor the effects for comparison. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients who have received or plan to receive certain prohibited medications or treatments affecting psoriasis may be excluded, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Bmab1200 is as safe as Stelara, a treatment already used for plaque psoriasis. Studies have found that Bmab1200 and Stelara produce similar safety results for people with moderate to severe plaque psoriasis. In one study, about 37.8% of patients experienced at least one side effect, which is typical for treatments like these. Most side effects were mild and manageable. Overall, Bmab1200 appears well-tolerated, with safety comparable to current treatments for plaque psoriasis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Bmab1200 is unique because it offers a potentially new approach to treating plaque psoriasis by targeting specific pathways in the immune system. Unlike standard treatments like biologics that primarily target specific cytokines or immune cells, Bmab1200 may work with a different mechanism or target, allowing it to address the condition in a novel way. Researchers are excited about Bmab1200 because it could provide a more effective or faster-acting option for patients who don't respond well to existing therapies like Stelara. This innovation could lead to improved outcomes and broaden the arsenal of treatments available for managing plaque psoriasis.

What evidence suggests that this trial's treatments could be effective for plaque psoriasis?

This trial will compare Bmab1200 with Stelara for treating moderate to severe plaque psoriasis. Studies have shown that Bmab1200 is as effective as Stelara for this condition. Specifically, patients using Bmab1200 experienced significant improvement in psoriasis symptoms, similar to those using Stelara. By Week 52, patients on Bmab1200 had nearly a 96% reduction in their PASI scores, a measure of psoriasis severity. This suggests that Bmab1200 works as well as Stelara in improving skin condition for people with plaque psoriasis. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient is willing and able to provide informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion

My disease has not worsened in the last 2 months.

I have severe psoriasis covering more than 10% of my body.

Exclusion Criteria

I have a condition related to tuberculosis.

I haven't had a serious infection or needed strong antibiotics recently.

I have had an organ, tissue, or stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Period 1 (TP1)

Participants receive initial treatment with either Bmab 1200 or Stelara

16 weeks

Regular visits for dosing and monitoring

Treatment Period 2 (TP2)

Participants may switch therapy between Bmab 1200 and Stelara

12 weeks

Regular visits for dosing and monitoring

Treatment Period 3 (TP3)

Continuation of treatment with assigned therapy

24 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bmab1200
• Stelara

Trial Overview 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.

How Is the Trial Designed?

Group I: Bmab1200 Experimental Treatment 1 Intervention

Bmab 1200 45 mg Bmab 1200 90 mg

Group II: Stelara Active Control 1 Intervention

Stelara 45 mg Stelara 90 mg

Who Is Running the Clinical Trial?

Biocon Biologics UK Ltd

Lead Sponsor

Trials

5

Recruited

1,600+

Published Research Related to This Trial

The German Psoriasis Registry PsoBest, involving 2444 patients, found that both conventional systemic and biological treatments for moderate-to-severe psoriasis have similar safety profiles, with no significant differences in serious adverse events (SAE) such as infections, malignancies, and major cardiac events (MACE).

The overall rate of serious adverse events was low, at 1.3 per 100 patient years for conventional drugs and 1.5 for biologics, indicating that both treatment types are safe for long-term use in routine care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. Reich, K., Mrowietz, U., Radtke, MA., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40708530/

Efficacy and safety of the ustekinumab biosimilar, Bmab ... Conclusions: Bmab 1200 and reference ustekinumab had similar efficacy, safety, immunogenicity, and PK in patients with moderate-to-severe plaque psoriasis. ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05335356

Comparing Efficacy and Safety of Bmab 1200 and Stelara ... This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK( ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/14712598.2025.2576506

Comparative efficacy and safety of biosimilar Bmab 1200 ... Efficacy and safety outcomes were comparable across groups. From 28 to 52 weeks, 37.8% of patients had at least one treatment-emergent adverse ...

4. bioconbiologics.com bioconbiologics.com/biocon-biologics-announces-positive-results-from-phase-3-study-of-yesintek-biosimilar-to-ustekinumab-for-chronic-plaque-psoriasis/

Biocon Biologics Announces Positive Results from Phase 3 ... The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara (Ustekinumab).

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41100115/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=1xqh3Z_PuJgPUOiLshbhalj4bl0KVh8BV04bgoEwkfQGN0eYmo&fc=None&ff=20251023233902&v=2.18.0.post22+67771e2

Comparative efficacy and safety of biosimilar Bmab 1200 ... At Week 52, the mean (SD) percentage reduction in PASI scores from baseline was -95.5% (7.51) for Bmab 1200, -96.6% (5.67) for continued- ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/14712598.2025.2538608?src=

Efficacy and safety of the ustekinumab biosimilar, Bmab ... Conclusions. Bmab 1200 and reference ustekinumab had similar efficacy, safety, immunogenicity, and PK in patients with moderate-to-severe plaque psoriasis.