Moderate to Severe Chronic Plaque PsoriasisPhase 3STELLAR-2NCT05335356
Comparing Efficacy and Safety of Bmab 1200 and Stelara in Patients With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study testing Stelara and Bmab1200 in people with Moderate to Severe Chronic Plaque Psoriasis, run by Biocon Biologics UK Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Moderate to Severe Chronic Plaque Psoriasis
- What is being tested?
- Stelara and Bmab1200
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2022to 15 Nov 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 10%, 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period.
- Patient who has prior exposure to more than 1 biologic agent for the treatment of psoriasis or psoriatic arthritis.
- Patient who has received or plans to receive any of the prohibited medications or treatment that could affect psoriasis:
- 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.
- 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.
- Have a transplanted organ/tissue or stem cell transplantation.
- TP3 specific criteria:
- 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
- Patient has not developed any condition/ or met study discontinuation or treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
About this study
Official title: 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.
Read the 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.
- Being tested
- Stelara, Bmab1200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StelaraBiological
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 .
Bmab1200Biological
45 mg , 90 mg at Week 0, 4, 16, 28 and 40
| Study group | Role | What they receive |
|---|---|---|
| Bmab1200 | Experimental | Bmab 1200 45 mg Bmab 1200 90 mg Receives: Biological: Bmab1200 |
| Stelara | Active comparator | Stelara 45 mg Stelara 90 mg Receives: Biological: Stelara |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)
Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12
Measured: Baseline to Week 12
Secondary outcomes (10)
PASI Score
Percentage change from baseline in the PASI score at Baseline through Week 28.
PASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score
Measured: Baseline through Week 28
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
PASI is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage, plaque appearance, their response to therapy. 4 regions- head, upper limbs, trunk, and lower limbs are assessed separately for erythema, induration/thickness, and scaling. Degree of involvement is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement) for each region. Total score (sum of erythema, thickness, and scaling) is multiplied by the degree of involvement for each body region and then multiplied by constant. Sum of all lesion scores can range from 0 (no disease) to 72 (maximal disease), with the higher score indicating more severe disease. Change from baseline in PASI score indicates response to therapy. PASI 50 means ≥50% reduction from baseline in the PASI score
Measured: Baseline through Week 28
Static Physician's Global Assessment (sPGA)
Change from Baseline in sPGA During TP2.
The sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status
Measured: Baseline through Week 28
Affected Body Surface Area
Change from baseline in affected body surface area at Weeks 28
Total % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement
Measured: Baseline through Week 28
Dermatology Life Quality Index Scores
Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 28
It is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.
Measured: Baseline through Week 28
Dermatology Life Quality Index Scores
Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 52
It is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Nine of the 10 questions have response categories including "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3); Question 7 is a "yes"/ "no" question where "yes" is scored as 3. Eight items also have a "Not relevant" option scored "0," which indicates no problems. Total scores range from 0 to 30 (less to more impairment) and a 5-point change from baseline is considered a clinically important difference.
Measured: Baseline through Week 52
Static Physician's Global Assessment (sPGA)
Change in Static Physician's Global Assessment (sPGA) at Weeks 52
The sPGA is a quantitative rating score of the patient's psoriasis based on physician's assessment at a given time point according to the following categories: induration, erythema, and scaling. The sPGA is a 6-point scale and patient's psoriasis is graded as clear (0), minimal (1), mild (2), moderate (3), marked (4), severe (5). The sum of the scores for induration, erythema, and scaling will be divided by 3 to obtain a final sPGA score. lower score indicates better disease status
Measured: Baseline through Week 52
Affected Body Surface Area
Change from baseline in affected body surface area at Weeks 52
Total % BSA afflicted by psoriasis is estimated using a handprint of the patient at each visit . The entire palmar surface of the patient's handprint is assumed to correspond to approximately 1% of total BSA. Reduction in BSA indicates improvement
Measured: Baseline through Week 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 Week 52
Measured: Baseline through week 52
PASI Score
Percentage change from baseline in the PASI score at Baseline through Week 52.
The PASI (Psoriasis Area and Severity Index) is a score from 0 to 72 that measures psoriasis severity based on lesion redness, thickness, scaling, and body area affected. The body is divided into four regions, each scored separately. Scores are calculated using severity and area involvement, and are used to assess treatment response (e.g., PASI 50 = 50% improvement).
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start28 Jun 2022
- Primary completion26 Jan 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335356
- Sponsor's protocol ID
- BM12H-PSO-03-G-02
- Acronym
- STELLAR-2
- Status last verified
- Aug 2025
- First submitted
- 13 Apr 2022
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krishnan A, Bp S, Mehta G, Ramaswamy S, Chakraborty S, Mandal S. From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars. Bioanalysis. 2026 Aug 26:1-14. doi: 10.1080/17576180.2026.2715917. Online ahead of print.
PubMed 42643157Szepietowski 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.
PubMed 41100115Szepietowski 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.
PubMed 40708530
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05335356
- Acronym / sponsor ID
- STELLAR-2 / BM12H-PSO-03-G-02
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Biocon Biologics UK LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bmab1200 | Experimental | Biological: Bmab1200Bmab 1200 45 mg Bmab 1200 90 mg |
| Stelara | Active comparator | Biological: StelaraStelara 45 mg Stelara 90 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Patient has stable disease for at least 2 months before the baseline visit (ie, without clinically significant changes in the investigator's opinion).
Key exclusion criteria (24 listed)
- 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:
- Patient meeting any of the following tuberculosis (TB)-related conditions:
- 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.
- Patient had a major surgical intervention within 12 weeks of the baseline or planned major surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stelara45 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 . | Biological | Stelara |
| Bmab120045 mg , 90 mg at Week 0, 4, 16, 28 and 40 | Biological | Bmab1200 |
Primary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline to Week 12
Percentage change from baseline in the Psoriasis Area and Severity Index score at Week 12
10 secondary outcomes
PASI Score
Time frame: Baseline through Week 28
PASI Improvement
Time frame: Baseline through Week 28
Static Physician's Global Assessment (sPGA)
Time frame: Baseline through Week 28
Affected Body Surface Area
Time frame: Baseline through Week 28
Dermatology Life Quality Index Scores
Time frame: Baseline through Week 28
Dermatology Life Quality Index Scores
Time frame: Baseline through Week 52
Static Physician's Global Assessment (sPGA)
Time frame: Baseline through Week 52
Affected Body Surface Area
Time frame: Baseline through Week 52
PASI Improvement
Time frame: Baseline through week 52
PASI Score
Time frame: Baseline through Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42643157Krishnan A, Bp S, Mehta G, Ramaswamy S, Chakraborty S, Mandal S. From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars. Bioanalysis. 2026 Aug 26:1-14. doi: 10.1080/17576180.2026.2715917. Online ahead of print.
- Derived from this study: PubMed 41100115Szepietowski 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.
- Derived from this study: PubMed 40708530Szepietowski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stelara and Bmab1200 in people with Moderate to Severe Chronic Plaque Psoriasis, run by Biocon Biologics UK Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335356, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.