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Plaque PsoriasisPhase 3NCT04728360

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

A Phase 3 study testing BAT2206 and Stelara (EU-sourced) in people with Plaque Psoriasis, run by Bio-Thera Solutions at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2206 with Stelara in patients with moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
BAT2206 and Stelara (EU-sourced)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
556 participants
Where
1 siteChina
Study dates
6 Jul 2021to 7 Jul 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 18 years old with a diagnosis of plaque-type psoriasis for at least 24 weeks before screening.
  • Have moderate to severe plaque-type psoriasis as defined at screening and baseline by:
  • PASI ≥ 12,
  • sPGA ≥ 3, and
  • body surface area affected by chronic plaque-type psoriasis ≥ 10%
  • Failed to respond to, or have a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate or psoralen and ultraviolet (UV) A
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  • Female patients of childbearing potential and male patients with a female partner of childbearing potential must be willing to use a highly effective contraceptive precaution throughout the study period and continuing for at least 15 weeks after the last dose of study drug. See APPENDIX 1 for the acceptable highly effective contraceptive methods. Abstinence from heterosexual intercourse is accepted when this is the usual lifestyle of the patient and must be continued for at least 15 weeks after the last dose of study drug. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
  • If female of childbearing potential, patient should have a negative pregnancy test result at screening and baseline visits.
  • Must be willing to provide written consent and to comply with the requirements of the study protocol.

Who cannot join

  • Have any forms of psoriasis at the time of the screening visit other than plaque-type such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
  • Have previously received ustekinumab, a biosimilar of ustekinumab, or any drug that targets interleukin-12 or interleukin-23.
  • Have received any biologic agents other than those prohibited (see exclusion #2) within 12 weeks or 5 half-lives (whichever is longer) before the baseline visit.
  • Have received topical therapies for the treatment of psoriasis (such as corticosteroids, vitamin D analogs, or retinoids) within 2 weeks before baseline visit.
  • Have received UVA phototherapy (with or without oral psoralen), UVB phototherapy, any systemic steroids or nonbiological drugs for the treatment of psoriasis within 4 weeks before baseline visit
  • Have received any investigational drug within 8 weeks or 5 half-lives (whichever is longer) before baseline visit
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  • Have received any herbal remedies or traditional medicines used to treat psoriasis within 4 weeks before baseline visit
  • History of allergy to the active substance or any of the excipients of study drugs, or of hypersensitivity to latex.
  • History of invasive infection (eg, histoplasmosis, coccidioidomycosis, blastomycosis).
  • Presence of active infection at screening, history of infection requiring intravenous antibiotics and/or hospitalization ≤ 8 weeks before baseline visit or oral antibiotics ≤ 2 weeks before baseline visit. Minor fungal infections may be allowed.
  • Any recurrent bacterial, fungal, or viral infection that, (based on the investigator´s clinical assessment), makes the patient unsuitable for the study, including recurrent/disseminated herpes zoster.
  • Meet any of the following criteria relative to latent or active tuberculosis (TB) infection.
  • Evidence of malignancy, lung infection, or abnormalities suggestive of active TB on chest radiography (x-ray or computed tomography) performed within 12 weeks before the screening visit or during the screening period.
  • Any history of malignancy or lymphoproliferative disease at any time, except curative treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.
  • Have a transplanted organ/tissue or stem cell transplantation.
  • Have an underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal condition, which in the opinion of the investigator places the patient at unacceptable risk.
  • Have a history of demyelinating diseases (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
  • Any major surgical procedure within 12 weeks of the baseline visit or planned during the study.
  • History of clinically significant drug or alcohol abuse in the last 12 months as judged by the investigator.
  • Pregnant or breastfeeding (lactating) women.
  • Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Patients participating in another investigational drug or device (a device is an instrument, apparatus, implement, machine, contrivance, or implant, including a component part or accessory intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease) trial or planning on participating in another clinical trial during the course of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2206 with Stelara in patients with moderate to severe plaque psoriasis.

The study is composed of a ≤ 28-day screening period, a 16-week initial treatment period (TP1), a 24-week secondary treatment period (TP2), a 12-week efficacy and safety follow-up period up to end-of-study visit, for a maximum total study duration of 56 weeks.

Being tested
BAT2206, Stelara (EU-sourced)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT2206Drug

    45 mg/0.5 mL

  • Stelara (EU-sourced)Drug

    45 mg/0.5 mL

Study groups in NCT04728360
Study groupRoleWhat they receive
BAT2206ExperimentalPatients who weigh ≤ 100 kg: BAT2206 45 mg (1 injection of 45 mg/0.5 mL) by SC injection via PFS. Patients who weigh > 100 kg: EU-sourced Stelara 90 mg (2 injections of 45 mg/0.5 mL each) by SC injection via PFS.
Receives: Drug: BAT2206
Stelara (EU-sourced)Active comparatorPatients who weigh ≤ 100 kg: EU-sourced Stelara 45 mg (1 injection of 45 mg/0.5 mL) by SC injection via PFS. Patients who weigh > 100 kg: EU-sourced Stelara 90 mg (2 injections of 45 mg/0.5 mL each) by SC injection via PFS.
Receives: Drug: Stelara (EU-sourced)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PASI

    Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score to Week 12

    Measured: 0-12 weeks

Secondary outcomes (3)

  1. PASI score

    Percent improvement from baseline in PASI score to Weeks 4, 8, 16, 20, 28, 40, and 52

    Measured: Weeks 4, 8, 16, 20, 28, 40, and 52

  2. PASI-50/75/90/100

    Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI-50/75/90/100) at Weeks 4, 8, 12, 16, 20, 28, 40, and 52

    Measured: Weeks 4, 8, 12, 16, 20, 28, 40, and 52

  3. Static Physician's Global Assessment (sPGA) score

    Change from baseline in static Physician's Global Assessment (sPGA) score to Weeks 4, 8, 12, 16, 20, 28, 40, and 52

    Measured: Weeks 4, 8, 12, 16, 20, 28, 40, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2021
  2. Study start6 Jul 2021
  3. Primary completion12 Oct 2022
  4. Study completion7 Jul 2023

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04728360
Sponsor's protocol ID
BAT-2206-002-CR
Status last verified
Aug 2022
First submitted
24 Jan 2021
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BAT2206 and Stelara (EU-sourced) in people with Plaque Psoriasis, run by Bio-Thera Solutions at 1 site in China.

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 22 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 21 Jul 2023. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PASI (time frame: 0-12 weeks). 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 NCT04728360.

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 21 Jul 2023.

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