What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis that target IL-12 and IL-23 include biologics like ustekinumab. Known side effects of these treatments can include upper respiratory infections, headache, tiredness, and injection site reactions. More serious but less common side effects may involve increased risk of infections, potential for malignancies, and hypersensitivity reactions. Patients should discuss these risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

Ustekinumab, an IL-12/23 inhibitor, has been approved by the FDA for the treatment of moderate-to-severe plaque psoriasis. It has been extensively studied for its efficacy and safety. Other related drugs include risankizumab, which targets IL-23 and has also been approved for similar indications. These biologic agents are part of a broader category of treatments that target specific pathways involved in the inflammatory process of plaque psoriasis.

What other types of research exist?

Promising, novel alternatives to Bmab 1200 for plaque psoriasis patients in 2024 include guselkumab, risankizumab, and brodalumab. These treatments target IL-23 or IL-17 pathways and have shown significant efficacy and safety in clinical trials.

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Monoclonal Antibodies

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

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

Pivotal Trial

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

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 28 and 52

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

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

Toothache

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 9Eligibility criteria met

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.