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

NCT05335356 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BM12H-PSO-03-G-02
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, active-controlled, parallel-group, multicenter study designed to compare the efficacy, safety, immunogenicity, and PK(Pharmacokinetic) of Bmab 1200 with Stelara in adult patients with moderate to severe chronic plaque psoriasis.

Conditions

Moderate to Severe Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Psoriasis Area and Severity Index (PASI)

  Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12

  Baseline to Week 12

Secondary Outcomes (10)

• PASI Score

  Baseline through Week 28

• PASI Improvement

  Baseline through Week 28

• Static Physician's Global Assessment (sPGA)

  Baseline through Week 28

• Affected Body Surface Area

  Baseline through Week 28

• Dermatology Life Quality Index Scores

  Baseline through Week 28

Other Outcomes (9)

• Safety:-Treatment-emergent Adverse Events Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period

  Baseline to Week 52

• Safety:- Injection-site Reactions

  Baseline through Week 28 and 52

• Safety:- Hypersensitivity

  Baseline through Week 52

Study Arms (2)

Bmab1200

EXPERIMENTAL

Bmab 1200 45 mg Bmab 1200 90 mg

Biological: Bmab1200

Stelara

ACTIVE COMPARATOR

Stelara 45 mg Stelara 90 mg

Biological: Stelara

Interventions

Stelara BIOLOGICAL

45 mg , 90 mg at Week 0, 4, 16, 28 and 40;During the study after receiving 2 doses , before dosing at Week 16 patients were re-randomised in a 1:1 ratio to receive either Bmab 1200 or Stelara .

Stelara

Bmab1200 BIOLOGICAL

45 mg , 90 mg at Week 0, 4, 16, 28 and 40

Bmab1200

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient is aged 18 to 80 years, both inclusive, and weighing \<130 kg at the time of the screening visit.
• Patient has a diagnosis of chronic plaque psoriasis for at least 6 months and is a candidate for systemic therapy or phototherapy at the time of the screening visit.
• Patient with moderate to severe chronic plaque psoriasis as defined by BSA (Body surface area)involvement
• %, PASI score ≥12, and sPGA ≥3 at the screening and baseline visits.
• Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion).
• Patient has adequate renal and hepatic function at the screening
• Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline. A female patient is considered not of childbearing potential when postmenopausal or surgically sterilized
• Women of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions.

You may not qualify if:

• Patient has nonplaque psoriasis, such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), other current or chronic systemic autoimmune or inflammatory disease at the time of screening visit that would interfere with the evaluation of the effect of the study treatment on psoriasis. Patients with concurrent psoriatic arthritis will be allowed to participate.
• Patient who has a current or past history of any of the following infections:
• Current or past history of congenital or acquired immunodeficiency or patient is positive for the human immunodeficiency virus (HIV) antibodies (HIV-1 or HIV-2) at screening.
• Patient has current infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) as per serological tests at screening.
• For HBV, patients who test positive to hepatitis B surface antigen (HBsAg) will be excluded. Patients who test positive to hepatitis B core antibody (HBcAb) only (HBsAg negative), may be enrolled if they also test positive to hepatitis B surface antibody (HBsAb).
• For HCV, patient who test positive to HCV antibody will be excluded unless they test negative for HCV RNA.
• Presence of active infection at screening or history of infection requiring intravenous antibiotics and/or hospitalization ≤8 weeks before baseline visit, or oral/intramuscular antibiotics ≤4 weeks before baseline visit, or topical antibiotics ≤2 weeks before baseline visit. Minor localized fungal infections or topical antibiotics for facial acne may be allowed.
• Any recurrent bacterial, fungal, opportunistic or viral infection including recurrent/disseminated herpes zoster that, based on the investigator´s clinical assessment, causes a safety risk and makes the patient unsuitable for the study.
• History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection.
• Patient meeting any of the following tuberculosis (TB)-related conditions:
• Patient who has current or history of active TB.
• Patient who has signs or symptoms suggestive of active TB upon medical history or physical examination including chest radiography at screening. If a chest radiography performed within the past 3 months before screening is available, it does not need to be repeated at screening.
• Patients with current latent TB (defined as a positive result of interferon-γ release assay \[IGRA\] with a negative examination of chest radiography \[posterior-anterior and lateral views, or per country regulations where applicable\] and absence of symptoms). Patients with positive IGRA (Interferon Gamma Release Assay) may be enrolled if they have documentation of completed appropriate country-specific TB prophylaxis within the past 5 years or have received at least 1 month of country-specific TB prophylaxis before the baseline visit and are willing to complete its entire course, and do not have other risk factors, radiologic findings, or physical evidence supporting latent or active TB. If a patient's initial IGRA test result is indeterminate, the test can be repeated once. If the test result is again indeterminate, the patient will be excluded from the study.
• Patient who has had exposure to a person with active TB, such as first-degree family members or coworkers within 16 weeks before the baseline visit.
• Patient has an underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic including central nervous system demyelinating disease, endocrine, cardiac, infection, or gastrointestinal) which, in the opinion of the investigator, significantly immune-compromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.

Sponsors & Collaborators

• Biocon Biologics UK Ltd: lead

Study Sites (1)

Apex Clinical Research Center

Mayfield Heights, Ohio, 44124, United States

Location

Related Publications (2)

• Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Wolff-Holz E, Athalye SN. Comparative efficacy and safety of biosimilar Bmab 1200 versus reference ustekinumab in moderate-to-severe plaque psoriasis: 52-week findings from the Phase 3 STELLAR-2 trial. Expert Opin Biol Ther. 2025 Oct;25(10):1121-1133. doi: 10.1080/14712598.2025.2576506. Epub 2025 Oct 21.

  PMID: 41100115 DERIVED

• Szepietowski JC, Reich A, Feldman SR, Pulka G, Mekokishvili L, Tsiskarishvili N, Svarca I, Poder A, Singh G, Deodhar S, Kumar K, Marwah A, Loganathan S, Athalye SN, Wolff-Holz E. Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28-week results of the randomized, double-blind, Phase 3 STELLAR-2 study. Expert Opin Biol Ther. 2025 Aug;25(8):913-924. doi: 10.1080/14712598.2025.2538608. Epub 2025 Jul 29.

  PMID: 40708530 DERIVED

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr Sarika D
• Organization: Biocon Biologics Limited

Sarika.Deodhar@biocon.com

080 2808

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blinded (Patient, Investigator),
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: June 28, 2022
• Primary Completion: January 26, 2023
• Study Completion: November 15, 2023
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)