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

NCT04728360 | Completed Phase 3

• 1 other identifier: BAT-2206-002-CR
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• PASI

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

  0-12 weeks

Secondary Outcomes (3)

• PASI score

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

• PASI-50/75/90/100

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

• Static Physician's Global Assessment (sPGA) score

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

Study Arms (2)

BAT2206

EXPERIMENTAL

Patients 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.

Drug: BAT2206

Stelara (EU-sourced)

ACTIVE COMPARATOR

Patients 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.

Drug: Stelara (EU-sourced)

Interventions

BAT2206 DRUG

45 mg/0.5 mL

BAT2206

Stelara (EU-sourced) DRUG

45 mg/0.5 mL

Stelara (EU-sourced)

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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 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
• 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.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

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

Study Officials

• Min Zheng

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: July 6, 2021
• Primary Completion: October 12, 2022
• Study Completion: July 7, 2023
• Last Updated: July 21, 2023

Record last verified: 2022-08

Locations

CN (1)