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Monoclonal Antibodies

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

Q: What is the status of Bmab1200's FDA approval process?

Bmab1200 has been found to be safe in multiple clinical trials, and thus it receives a safety score of 3.

Q: Are patients being sought out for this type of research currently?

That is correct. The online clinicaltrials.gov registry reveals that, as of 7/14/2022, this trial is still actively looking for participants. This trial was originally posted on 6/28/2022 and is searching for a total of 384 patients at 1 location.

Q: Does the age limit for this research study make anyone ineligible?

In order to be eligible for this study, applicants must be aged 18 to 80. There are currently 32 clinical trials underway for patients under 18 and 154 for those over 65.

Q: What are the aims of this scientific research being conducted with human subjects?

The goal of this trial, which will be monitored over roughly Baseline to Week 12, is to Severity Index. Secondary outcomes include Affected body surface area, PASI improvement, and Dermatology Life Quality Index scores.

Q: Are there any limitations on the total number of participants for this trial?

That is correct. The listing on clinicaltrials.gov verifies that this clinical trial is still recruiting patients. This trial was first posted on June 28th, 2022 and was edited on July 14th, 2022. Up to 384 patients can be enrolled from a single site.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 28 and 52

Awards & highlights

STELLAR-2 Trial Summary

This trial is testing a new medication for plaque psoriasis to see if it is better than the current standard of care.

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.Check my eligibility

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.See study design

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.

STELLAR-2 Trial 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.

STELLAR-2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Psoriasis Area and Severity Index (PASI)

Secondary outcome measures

Affected body surface area

Dermatology Life Quality Index scores

PASI improvement

+2 more

Other outcome measures

Developing neutralizing antibodies

Immunogenicity:-Developing antidrug antibodies

Pharmacokinetic:-Serum concentrations

+3 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Urinary tract infection

Anxiety

Back pain

Dizziness

Fracture

Skin and subcutaneous tissue disorders

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)

STELLAR-2 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

0 / 4Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the status of Bmab1200's FDA approval process?

"Bmab1200 has been found to be safe in multiple clinical trials, and thus it receives a safety score of 3."

Answered by AI

Are patients being sought out for this type of research currently?

"That is correct. The online clinicaltrials.gov registry reveals that, as of 7/14/2022, this trial is still actively looking for participants. This trial was originally posted on 6/28/2022 and is searching for a total of 384 patients at 1 location."

Answered by AI

Does the age limit for this research study make anyone ineligible?

"In order to be eligible for this study, applicants must be aged 18 to 80. There are currently 32 clinical trials underway for patients under 18 and 154 for those over 65."

Answered by AI

What are the aims of this scientific research being conducted with human subjects?

"The goal of this trial, which will be monitored over roughly Baseline to Week 12, is to Severity Index. Secondary outcomes include Affected body surface area, PASI improvement, and Dermatology Life Quality Index scores."

Answered by AI

Are there any limitations on the total number of participants for this trial?

"That is correct. The listing on clinicaltrials.gov verifies that this clinical trial is still recruiting patients. This trial was first posted on June 28th, 2022 and was edited on July 14th, 2022. Up to 384 patients can be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05335356.

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