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

384 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What is the safety profile of Bmab1200 and Stelara for plaque psoriasis?

Stelara (ustekinumab) is generally well tolerated, with most side effects being mild and not requiring dosage changes. In a German registry study, biologic drugs like Stelara showed a low rate of serious adverse events, including infections and heart issues, similar to conventional treatments. No specific safety data for Bmab1200 was found in the provided research. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Drug safety of systemic treatments for psoriasis: results from The German Psoriasis Registry PsoBest. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of apremilast monotherapy in moderate-to-severe plaque psoriasis: A systematic review and meta-analysis. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on ustekinumab in moderate to severe plaque psoriasis. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Real-world experience of secukinumab in moderate to severe psoriasis patients in Thailand: Characteristics, effectiveness, and safety. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Trial proves apremilast is effective long-term treatment for psoriasis. [2017]