- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment closed, Trial completion date, Trial primary completion date: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Mar 9, 2023
P2b, N=320, Active, not recruiting,
These results informed the design and dose selection of a phase 2b study assessing the safety and efficacy of rozibafusp alfa in patients with active systemic lupus erythematosus. Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jul 2023 | Trial primary completion date: Sep 2024 --> Jul 2023
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Trial completion date, Trial primary completion date: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Jan 6, 2023
P2b, N=320, Recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jul 2023 | Trial primary completion date: Sep 2024 --> Jul 2023 Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Mar 2024 --> Sep 2024
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Clinical, P1 data, Journal: Safety and Biological Activity of Rozibafusp alfa, a Bispecific Inhibitor of Inducible Costimulator Ligand and B Cell Activating Factor, in Patients With Rheumatoid Arthritis: Results of a Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study. (Pubmed Central) - Jul 29, 2022
Multiple ascending doses of rozibafusp alfa were well tolerated, with PK and PD reflecting dual ICOSL and BAFF blockade. Findings support further clinical evaluation of rozibafusp alfa in autoimmune disease.
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Trial completion date, Trial primary completion date: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Mar 4, 2022
P2b, N=320, Recruiting,
Findings support further clinical evaluation of rozibafusp alfa in autoimmune disease. Trial completion date: Oct 2023 --> Jul 2024 | Trial primary completion date: May 2023 --> Mar 2024
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Jan 26, 2021
P2b, N=320, Active, not recruiting,
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | Phase classification: P2 --> P2b | Trial completion date: Sep 2023 --> Mar 2024 | Trial primary completion date: Nov 2022 --> May 2023
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment open: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Sep 17, 2020
P2, N=300, Recruiting,
These findings informed the design and dose selection of an ongoing phase 2, randomized, placebo-controlled study to assess the efficacy and safety of rozibafusp alfa in subjects with active SLE and inadequate responses to standard of care therapy. Active, not recruiting --> Recruiting
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment closed, Trial completion date, Trial primary completion date: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - May 26, 2020
P2, N=300, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Oct 2020 --> Jun 2020 Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Sep 2023 | Trial primary completion date: Jul 2022 --> Nov 2022
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
[VIRTUAL] SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, IMMUNOGENICITY, AND PRELIMINARY EFFICACY OF ROZIBAFUSP ALFA IN SUBJECTS WITH RHEUMATOID ARTHRITIS: INTERIM ANALYSIS OF A PHASE 1B RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE ASCENDING DOSE CLINICAL TRIAL (Poster View) - May 22, 2020 - Abstract #EULAR2020EULAR_4269;
P1
PK/PD analysis demonstrated nonlinear, target-mediated disposition consistent with cell surface target interaction and PD activity consistent with dual ICOSL/BAFF neutralization. These findings informed the design and dose selection of an ongoing phase 2, randomized, placebo-controlled study to assess the efficacy and safety of rozibafusp alfa in subjects with active SLE and inadequate responses to standard of care therapy.
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment open: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Mar 20, 2020
P2, N=300, Recruiting,
These findings informed the design and dose selection of an ongoing phase 2, randomized, placebo-controlled study to assess the efficacy and safety of rozibafusp alfa in subjects with active SLE and inadequate responses to standard of care therapy. Not yet recruiting --> Recruiting
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Trial completion date, Trial initiation date, Trial primary completion date: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Jan 13, 2020
P2, N=300, Not yet recruiting,
Trial completion date: Aug 2023 --> Mar 2023 | Trial primary completion date: Oct 2022 --> May 2022 Trial completion date: Mar 2023 --> Aug 2023 | Initiation date: Dec 2019 --> Mar 2020 | Trial primary completion date: Apr 2022 --> Oct 2022
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Trial completion date: Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - Nov 7, 2019
P1, N=34, Active, not recruiting,
By targeting both ICOSL and BAFF, AMG 570 has the potential to achieve superior efficacy in treatment of autoimmune diseases such as SLE and rheumatoid arthritis. Trial completion date: Oct 2019 --> Oct 2020
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment closed, Trial completion date, Trial primary completion date: Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - Mar 7, 2019
P1, N=34, Active, not recruiting,
Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Nov 2021 --> May 2022 Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Oct 2019 | Trial primary completion date: Jun 2019 --> Oct 2019
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Trial completion: Single Ascending Dose Study of AMG 570 in Healthy Subjects (clinicaltrials.gov) - Sep 11, 2018
P1, N=56, Completed,
Recruiting --> Active, not recruiting | Trial completion date: Jun 2019 --> Oct 2019 | Trial primary completion date: Jun 2019 --> Oct 2019 Active, not recruiting --> Completed
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment closed: Single Ascending Dose Study of AMG 570 in Healthy Subjects (clinicaltrials.gov) - Jun 21, 2018
P1, N=56, Active, not recruiting,
N=24 --> 32 | Trial completion date: Jan 2019 --> May 2019 | Trial primary completion date: Jan 2019 --> May 2019 Recruiting --> Active, not recruiting
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Enrollment open, Trial completion date: Single Ascending Dose Study of AMG 570 in Healthy Subjects (clinicaltrials.gov) - Apr 13, 2018
P1, N=56, Recruiting,
Trial completion date: Oct 2018 --> Jan 2019 | Trial primary completion date: Oct 2018 --> Jan 2019 Active, not recruiting --> Recruiting | Trial completion date: Nov 2018 --> Aug 2018
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Trial primary completion date: Single Ascending Dose Study of AMG 570 in Healthy Subjects (clinicaltrials.gov) - Dec 19, 2017
P1, N=48, Active, not recruiting,
Active, not recruiting --> Recruiting | Trial completion date: Nov 2018 --> Aug 2018 Trial primary completion date: Mar 2018 --> Jul 2018
- |||||||||| rozibafusp alfa (AMG 570) / AstraZeneca, Amgen
Clinical: Single Ascending Dose Study of AMG 570 in Healthy Subjects (clinicaltrials.gov) - Dec 5, 2017
P1, N=48, Active, not recruiting,
Trial primary completion date: Mar 2018 --> Jul 2018 Trial primary completion date: Nov 2017 --> Mar 2018
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