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61 News |  |
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- || BI 655064 / AbbVie, Boehringer Ingelheim
Biomarker, Clinical, P2 data, Journal, IO biomarker: Clinical and biomarker responses to BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: a randomized, double-blind, placebo-controlled, phase II trial. (Pubmed Central) - May 16, 2023
The trial failed to demonstrate a dose-response relationship for the primary CRR endpoint. Post-hoc analyses suggest a potential benefit of BI 655064 180mg in patients with active LN.
- BI 655064 / AbbVie, Boehringer Ingelheim
RELATION OF KIDNEY BIOPSY FINDINGS TO CLINICAL OUTCOMES IN PATIENTS WITH LUPUS NEPHRITIS TREATED WITH AN ANTAGONISTIC ANTI-CD40 ANTIBODY (BI 655064) (Focussed Oral Room 9) - May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_1756;
Although the number of patients was limited, our results suggest that treatment with higher dose anti-CD40 may improve the reduction of proteinuria when monocytes are present in the biopsy. This indicates that specific information from renal biopsies could ultimately improve the choice of treatment for individual LN patients.
- | BI 655064 / AbbVie, Boehringer Ingelheim, BI-1 / Boehringer Ingelheim
Journal: An optimally designed anti-human CD40 antibody with potent B cell suppression for the treatment of autoimmune diseases. (Pubmed Central) - Nov 11, 2021
This uniquely optimized antibody targeting a highly challenging pathway was obtained by applying stringent functional and biophysical criteria during the lead selection process. BI 655064 has favorable target-mediated drug disposition (TMDD)-saturation pharmacokinetics, consistent with that of a high-quality therapeutic monoclonal antibody.
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Jul 30, 2021
P2, N=69, Completed, Sponsor: Boehringer Ingelheim
BI 655064 has favorable target-mediated drug disposition (TMDD)-saturation pharmacokinetics, consistent with that of a high-quality therapeutic monoclonal antibody. Active, not recruiting --> Completed
- || BI 655064 / AbbVie, Boehringer Ingelheim
Clinical, P1 data, PK/PD data, Journal: Safety, Pharmacokinetics and Pharmacodynamics of BI 655064 in Phase 1 Clinical Trials in Healthy Chinese and Japanese Subjects. (Pubmed Central) - Jul 28, 2021
BI 655064 pharmacokinetic and safety profiles in East Asian male subjects were consistent with those observed in a Western population. No adjustments in the BI 655064 dosing recommendations are warranted for future clinical trials.
- BI 655064 / AbbVie, Boehringer Ingelheim
[VIRTUAL] A RANDOMISED DOSE RANGING, PLACEBO-CONTROLLED, PHASE II STUDY ASSESSING THE EFFICACY AND SAFETY OF BI 655064, AN ANTAGONISTIC ANTI-CD40 ANTIBODY, IN PATIENTS WITH LUPUS NEPHRITIS (Posters Viewing) - May 21, 2021 - Abstract #EULAR2021EULAR_3156;
P2
However, when confirmation of CRR was required at both Weeks 46 and 52, the resultant decrease in the placebo response generated an effect size of 15.2% and 9.1% in favour of 180 mg and 240 mg BI 655064, respectively. Efficacy endpoints at Week 52 CRR based on 24 h proteinuria; cCRR based on UP/UC (spot urine) at Weeks 46 and 52.
- BI 655064 / AbbVie, Boehringer Ingelheim
[VIRTUAL] A RANDOMISED DOSE RANGING, PLACEBO-CONTROLLED, PHASE II STUDY ASSESSING THE EFFICACY AND SAFETY OF BI 655064, AN ANTAGONISTIC ANTI-CD40 ANTIBODY, IN PATIENTS WITH LUPUS NEPHRITIS (Hall London) - Mar 19, 2021 - Abstract #ERAEDTA2021ERA_EDTA_800;
P2
However, when confirmation of CRR was required at both Wks 46 and 52, the resultant decrease in the placebo response generated an effect size of 15.2% and 9.1% in favour of 180 mg and 240 mg BI 655064, respectively. Table 1.
- || BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Feb 23, 2021
P2, N=69, Active, not recruiting, Sponsor: Boehringer Ingelheim
Table 1. Recruiting --> Active, not recruiting
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment open: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Jan 14, 2021
P2, N=69, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Nov 4, 2020
P2, N=69, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | N=170 --> 69 | Trial completion date: Dec 2022 --> Aug 2021 | Trial primary completion date: Oct 2022 --> May 2021
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Aug 24, 2020
P2, N=121, Completed, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting | N=170 --> 69 | Trial completion date: Dec 2022 --> Aug 2021 | Trial primary completion date: Oct 2022 --> May 2021 Active, not recruiting --> Completed
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Jul 15, 2020
P2, N=0, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Trial primary completion date: Dec 2019 --> Jun 2020
- || BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed, Trial primary completion date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - May 26, 2020
P2, N=121, Active, not recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Dec 2019 --> Jun 2020 Trial primary completion date: Jun 2020 --> Dec 2019 | Recruiting --> Active, not recruiting
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment open: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - May 20, 2020
P2, N=120, Recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Jun 2020 --> Dec 2019 | Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting
- || BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Apr 27, 2020
P2, N=121, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Recruiting Trial primary completion date: Dec 2019 --> Jun 2020
- || BI 655064 / AbbVie, Boehringer Ingelheim
Biomarker, Clinical, P2a data, Journal, IO Biomarker: Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker parameters in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study. (Pubmed Central) - Jan 30, 2020
P1
Trial primary completion date: Dec 2019 --> Jun 2020 Although blockade of the CD40-CD40L pathway with BI 655064 in MTX-IR patients with RA resulted in marked changes in clinical and biological parameters, including reductions in activated B-cells, autoantibody production and inflammatory and bone resorption markers, with a favourable safety profile, clinical efficacy was not demonstrated in this small phase IIa study.
- | BI 655064 / AbbVie, Boehringer Ingelheim
Clinical, PK/PD data, Journal: Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 655064, an Antagonistic Anti-CD40 Antibody, in Healthy Subjects: A Potential Novel Treatment for Autoimmune Diseases. (Pubmed Central) - Nov 2, 2019
There were no serious adverse events and the frequency and intensity of adverse events were similar for BI 655064 and placebo; no dose relationship or relevant signs of an acute immune reaction were observed. These findings support further investigation of BI 655064 as a potential treatment for autoimmune diseases.
- | BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion date, Trial primary completion date: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Oct 1, 2019
P2, N=150, Recruiting, Sponsor: Boehringer Ingelheim
These findings support further investigation of BI 655064 as a potential treatment for autoimmune diseases. Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Oct 2022
- | BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Jul 17, 2019
P2, N=121, Active, not recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Oct 2022 Recruiting --> Active, not recruiting
- |||| BI 655064 / AbbVie, Boehringer Ingelheim
Clinical: Efficacy Not Demonstrated by BI 655064 in #RheumatoidArthritis - Another example why a #PrecisionMedicine strategies must become a key element in #drugdevelopment to potentially identify reasons for failure and save #costs #rheumtaology https://t.co/gyKxom28uL @Boehringer (Twitter) - May 9, 2019
- ||||| BI 655064 / AbbVie, Boehringer Ingelheim
New P2 trial: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Jan 26, 2018
P2, N=150, Recruiting, Sponsor: Boehringer Ingelheim
- |||| BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment open, Enrollment change, Trial primary completion date: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Jan 26, 2018
P2, N=150, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | N=60 --> 150 | Trial primary completion date: Aug 2020 --> Mar 2022
- || BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Jan 24, 2018
P2, N=120, Recruiting, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting | N=60 --> 150 | Trial primary completion date: Aug 2020 --> Mar 2022 Trial primary completion date: Aug 2019 --> Dec 2019
- ||||| BI 655064 / AbbVie, Boehringer Ingelheim
New P2 trial: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis (clinicaltrials.gov) - Dec 27, 2017
P2, N=60, Not yet recruiting, Sponsor: Boehringer Ingelheim
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Trial initiation date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - May 16, 2017
P2, N=120, Recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Aug 2019 --> Dec 2019 Initiation date: Jan 2016 --> May 2016
- || BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Apr 19, 2017
P2, N=120, Recruiting, Sponsor: Boehringer Ingelheim
Initiation date: Jan 2016 --> May 2016 Trial primary completion date: Mar 2019 --> Aug 2019
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Trial initiation date, Trial primary completion date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Feb 15, 2017
P2, N=120, Recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Mar 2019 --> Aug 2019 Initiation date: May 2016 --> Jan 2016 | Trial primary completion date: Oct 2018 --> Mar 2019
- || BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Oct 21, 2016
P2, N=120, Recruiting, Sponsor: Boehringer Ingelheim
Initiation date: May 2016 --> Jan 2016 | Trial primary completion date: Oct 2018 --> Mar 2019 Trial primary completion date: Jun 2018 --> Oct 2018
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial termination: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - Sep 29, 2016
P1, N=6, Terminated, Sponsor: Boehringer Ingelheim
Trial primary completion date: Jun 2018 --> Oct 2018 Completed --> Terminated
- |||| BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment open: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - Jun 11, 2016
P2, N=120, Recruiting, Sponsor: Boehringer Ingelheim
Completed --> Terminated Not yet recruiting --> Recruiting
- | BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion: Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers (clinicaltrials.gov) - Jun 1, 2016
P1, N=12, Completed, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||||| BI 655064 / AbbVie, Boehringer Ingelheim
New P2 trial: Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis (clinicaltrials.gov) - May 12, 2016
P2, N=120, Not yet recruiting, Sponsor: Boehringer Ingelheim
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - May 4, 2016
P1, N=3, Completed, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Active, not recruiting --> Completed
- BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment change: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - Jan 28, 2016
P1, N=6, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed N=10 --> 6
- BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - Nov 15, 2015
P1, N=10, Active, not recruiting, Sponsor: Boehringer Ingelheim
N=10 --> 6 Recruiting --> Active, not recruiting
- BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed: Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers (clinicaltrials.gov) - Oct 28, 2015
P1, N=12, Active, not recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting
- BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment change, Trial withdrawal: Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers (clinicaltrials.gov) - Jun 23, 2015
P1, N=0, Withdrawn, Sponsor: Boehringer Ingelheim
Not yet recruiting --> Active, not recruiting N=12 --> 0 | Not yet recruiting --> Withdrawn
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - Jun 11, 2015
P1, N=10, Recruiting, Sponsor: Boehringer Ingelheim
N=12 --> 0 | Not yet recruiting --> Withdrawn Trial primary completion date: Feb 2016 --> May 2016
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial initiation date, Trial primary completion date: Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers (clinicaltrials.gov) - Jun 11, 2015
P1, N=12, Not yet recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Feb 2016 --> May 2016 Initiation date: Jan 2015 --> Jul 2015 | Trial primary completion date: Jun 2015 --> Apr 2016
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy (clinicaltrials.gov) - May 12, 2015
P1, N=107, Completed, Sponsor: Boehringer Ingelheim
Initiation date: Jan 2015 --> Jul 2015 | Trial primary completion date: Jun 2015 --> Apr 2016 Active, not recruiting --> Completed
- || BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy (clinicaltrials.gov) - Jan 8, 2015
P1, N=106, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | BI 655064 / AbbVie, Boehringer Ingelheim
New P1 trial: Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers (clinicaltrials.gov) - Jan 6, 2015
P1, N=12, Not yet recruiting, Sponsor: Boehringer Ingelheim
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - Oct 10, 2014
P1, N=10, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Trial primary completion date: Oct 2015 --> Feb 2016
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - May 18, 2014
P1, N=10, Recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Oct 2015 --> Feb 2016 Trial primary completion date: Sep 2015 --> Oct 2015
- || BI 655064 / AbbVie, Boehringer Ingelheim
Trial primary completion date: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy (clinicaltrials.gov) - May 18, 2014
P1, N=106, Recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Sep 2015 --> Oct 2015 Trial primary completion date: Oct 2014 --> Apr 2015
- BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion date: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - May 18, 2014
P1, N=10, Recruiting, Sponsor: Boehringer Ingelheim
Trial primary completion date: Oct 2014 --> Apr 2015 Trial completion date: Sep 2015 --> Oct 2015
- | BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion date: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy (clinicaltrials.gov) - May 18, 2014
P1, N=106, Recruiting, Sponsor: Boehringer Ingelheim
Trial completion date: Sep 2015 --> Oct 2015 Trial completion date: Dec 2014 --> Jun 2015
- ||| BI 655064 / AbbVie, Boehringer Ingelheim
Trial completion: Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers (clinicaltrials.gov) - May 18, 2014
P1, N=64, Completed, Sponsor: Boehringer Ingelheim
Trial completion date: Dec 2014 --> Jun 2015 Active, not recruiting --> Completed
- || BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment closed: Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers (clinicaltrials.gov) - Mar 18, 2014
P1, N=64, Active, not recruiting, Sponsor: Boehringer Ingelheim
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- BI 655064 / AbbVie, Boehringer Ingelheim
Enrollment open: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP). (clinicaltrials.gov) - Jan 7, 2014
P1, N=10, Recruiting, Sponsor: Boehringer Ingelheim
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting