- |||||||||| Stelara (ustekinumab) / J&J, BAT2206 (ustekinumab biosimilar) - Bio / Thera Solutions, Pharmapark, Hikma, Biomm
A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 with Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_4751;
The current study showed that BAT2206 and Ustekinumab are similar in terms of efficacy, safety, PK, and immunogenicity. Additionally, the transition from Ustekinumab to BAT2206 in TP2 had no impact on efficacy, safety, PK, or immunogenicity.
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Trial completion, Trial primary completion date: Comparative Study of BAT2206 With Stelara (clinicaltrials.gov) - Jul 21, 2023
P3, N=556, Completed,
Additionally, the transition from Ustekinumab to BAT2206 in TP2 had no impact on efficacy, safety, PK, or immunogenicity. Active, not recruiting --> Completed | Trial primary completion date: Apr 2023 --> Oct 2022
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P1 data, PK/PD data, Journal: Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. (Pubmed Central) - Nov 24, 2022
P1
Pharmacokinetic similarity between BAT2206 and ustekinumab (USA or European Union sourced) was confirmed. The three groups had similar safety profiles, and the investigational drugs were well tolerated by subjects.
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Enrollment closed, Enrollment change: Comparative Study of BAT2206 With Stelara (clinicaltrials.gov) - Aug 19, 2022
P3, N=556, Active, not recruiting,
The three groups had similar safety profiles, and the investigational drugs were well tolerated by subjects. Recruiting --> Active, not recruiting | N=406 --> 556
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Enrollment open, Trial initiation date, Trial primary completion date: Comparative Study of BAT2206 With Stelara (clinicaltrials.gov) - Sep 30, 2021
P3, N=406, Recruiting,
Recruiting --> Active, not recruiting | N=406 --> 556 Not yet recruiting --> Recruiting | Initiation date: Feb 2021 --> Jul 2021 | Trial primary completion date: Nov 2022 --> Apr 2023
- |||||||||| BAT2206 (ustekinumab biosimilar) - Bio / Thera Solutions, Pharmapark, Hikma, Biomm
Trial completion, Trial completion date: Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara (clinicaltrials.gov) - Sep 13, 2021
P1, N=270, Completed,
Not yet recruiting --> Recruiting | Initiation date: Feb 2021 --> Jul 2021 | Trial primary completion date: Nov 2022 --> Apr 2023 Not yet recruiting --> Completed | Trial completion date: Sep 2021 --> Apr 2021
- |||||||||| BAT2206 (ustekinumab biosimilar) - Bio / Thera Solutions, Pharmapark, Hikma, Biomm
New P3 trial: Comparative Study of BAT2206 With Stelara (clinicaltrials.gov) - Jan 27, 2021
P3, N=406, Not yet recruiting,
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