Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis (STELLAR-2)

A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate to Severe Chronic Plaque Psoriasis
• Intervention / Treatment: Biological: Bmab1200; Biological: Stelara

Detailed Description

Approximately 384 patients with moderate to severe plaque psoriasis will be enrolled and randomly assigned to one of the 2 treatment groups in a 1:1 ratio (192 patients in the Bmab 1200 group and 192 patients in the Stelara group). Patients who are diagnosed as moderate to severe chronic plaque psoriasis for at least 6 months and are candidate for systemic therapy or phototherapy at the time of the screening visit will be enrolled. The study is planned to be conducted in Europe and North America across approximately 48 sites in 5 countries. The study will be conducted in an outpatient setting, and the participation for each patient will consist of a screening period (up to 4 weeks/28 days) and a double-blind, active-controlled treatment period (52 weeks) with a rerandomization step for switching therapy (Bmab 1200 with Stelara ) before Week 16 dosing. The treatment period before the switch is TP1(Treatment Period1) and post switch is TP2(Treatment Period 2) (from Week 16 dosing to prior to Week 28 dosing) and TP3 (Treatment Period3)(from Week 28 dosing to Week 52). The total duration of the study (excluding the screening period) will be 52 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sivakumar Vaidyanathan, M Pharm; Phone Number: 5466 080 2808; Email: sivakumar.vaidyanathan@biocon.com
• Study Contact Backup: Name: Dr Gursharan Singh; Phone Number: 5479 080 2808; Email: gursharan.singh@biocon.com

Study Locations

• United States
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Apex Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Patient is aged 18 to 80 years, both inclusive, and weighing <130 kg at the time of the screening visit.
3. 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.

4. 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.
5. Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion).
6. Patient has adequate renal and hepatic function at the screening
7. 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
8. Women of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions.

Exclusion Criteria:

1. 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.

2. Patient who has a current or past history of any of the following infections:

   1. 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.

   2. 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.
   3. 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.
   4. 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.
   5. History of invasive/systemic fungal infection (eg, histoplasmosis) or nontubercular mycobacterial infection.

3. Patient meeting any of the following tuberculosis (TB)-related conditions:

   1. Patient who has current or history of active TB.
   2. 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.
   3. 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.
   4. 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.
4. 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.
5. Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period.
6. Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis.
7. Patient who has received or plans to receive any of the prohibited medications or treatment that could affect psoriasis:
8. Patient has received a live or live-attenuated vaccine within 4 weeks before the baseline visit. Patient must agree not to receive a live or live-attenuated vaccine during the study and up to 15 weeks after the last dose of the study treatment.
9. Patient who has had Bacillus Calmette-Guérin (BCG) vaccination within 1 year before the baseline visit. Patients must agree not to receive a BCG vaccination during the study and at least 1 year after the last dose of the study treatment.
10. Have a transplanted organ/tissue or stem cell transplantation.

11. TP3 specific criteria:

    1. Patient is willing and able to provide revised informed consent form (ICF), able to follow study instructions, and comply with the protocol requirements as per the investigator's opinion
    2. Patient has not developed any condition/ or met study discontinuation or treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bmab1200; Bmab 1200 45 mg Bmab 1200 90 mg	Biological: Bmab1200; 45 mg , 90 mg at Week 0, 4, 16, 28 and 40
Active Comparator: Stelara; Stelara 45 mg Stelara 90 mg	Biological: Stelara; 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index (PASI)	Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12 and 52	Baseline to Week 12 and 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI score	Percentage change from baseline in the PASI score at Baseline through Week 28 and 52	Baseline through Week 28 and 52
PASI improvement	PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75% relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Baseline through Week 28 and 52	Baseline through Week 28 and 52
Static Physician's Global Assessment (sPGA)	Static Physician's Global Assessment (sPGA) response of cleared or almost clear/minimal (PGA of 0 or 1) at Weeks 4, 8, 12, 16, 20, 28, and 52	Baseline through Week 28 and 52
Affected body surface area	Change from baseline in affected body surface area at Weeks 4, 8, 12, 16, 20, 28 and 52	Baseline through Week 28 and 52
Dermatology Life Quality Index scores	Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 4, 8, 12, 16, 20, 28 and 52	Baseline through Week 28 and 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Developing neutralizing antibodies	Proportion of patients neutralizing antibodies	Baseline through Week 28
Pharmacokinetic:-Serum concentrations	Serum concentrations of ustekinumab	Baseline through Week 28]
Safety:-Treatment-emergent adverse events including adverse events of special interest and adverse reactions during the treatment period		Baseline through Week 28 and 52
Safety:- Injection-site reactions	Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study	Baseline through Week 28 and 52
Safety:- Hypersensitivity	Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study	Baseline through Week 28 and 52
Immunogenicity:-Developing antidrug antibodies	Proportion of patients developing antidrug antibodies	Baseline through Week 28
Immunogenicity:-Developing antidrug antibodies	Proportion of patients developing antidrug antibodies	Postdosing on Week 28 through Week 52
Developing neutralizing antibodies	Proportion of patients neutralizing antibodies	Postdosing on Week 28 through Week 52
Pharmacokinetic:-Serum concentrations	Serum concentrations of ustekinumab	Postdosing on Week 28 through Week 52

Collaborators and Investigators

• Sponsor: Biocon Biologics UK Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Actual): January 26, 2023
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: BM12H-PSO-03-G-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No