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- | Journal: Costimulation blockade: the next generation. (Pubmed Central) - Jan 30, 2025
Investigational agents with subcutaneous delivery methods could overcome logistical challenges, improve adherence, and redefine posttransplant care. These advancements in costimulation blockade may enhance long-term graft survival and transform the management of KT recipients.
- || Review, Journal: New Developments and Therapeutic Drug Monitoring Options in Costimulatory Blockade in Solid Organ Transplantation: A Systematic Critical Review. (Pubmed Central) - Jan 8, 2025
Costimulatory inhibitors could be combined in a calcineurin inhibitor-free regimen. Future PK/pharmacodynamic studies in costimulatory agents and personalized medicine could warrant TDM of these agents.
- | dazodalibep (HZN-4920) / Amgen
Phase classification: A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis (clinicaltrials.gov) - Dec 27, 2024
P1, N=57, Completed, Sponsor: Amgen
Future PK/pharmacodynamic studies in costimulatory agents and personalized medicine could warrant TDM of these agents. Phase classification: P1b --> P1
- dazodalibep (HZN-4920) / Amgen
Phase classification: A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant (clinicaltrials.gov) - Dec 27, 2024
P2, N=25, Completed, Sponsor: Amgen
Phase classification: P1b --> P1 Phase classification: P2a --> P2
- |||||||||| dazodalibep (HZN-4920) / Amgen
New P3 trial: A Long-term Extension Study of Dazodalibep in Participants With Sj (clinicaltrials.gov) - Dec 26, 2024
P3, N=844, Not yet recruiting, Sponsor: Amgen
- || Review, Journal: Infections in Sj (Pubmed Central) - Dec 19, 2024
Emerging therapies, such as ianalumab, iscalimab, dazodalibep, and remibrutinib, show efficacy in reducing disease activity but also present infection risks, with reports of upper respiratory infections and serious cases, including pneumonia and COVID-19. By exploring these infection-related challenges, this review underscores the importance of understanding the infection-autoimmunity relationship to improve outcomes for patients with SjD and similar autoimmune conditions.
- | dazodalibep (HZN-4920) / Amgen
Trial completion date, Trial primary completion date: CONTROL-RA: CD40L Antagonism in Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Sep 5, 2024
P2, N=104, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
By exploring these infection-related challenges, this review underscores the importance of understanding the infection-autoimmunity relationship to improve outcomes for patients with SjD and similar autoimmune conditions. Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Aug 2024 --> Aug 2025
- || dazodalibep (HZN-4920) / Amgen
Clinical, P2 data, Journal: CD40 ligand antagonist dazodalibep in Sj (Pubmed Central) - Jun 19, 2024
P2
In summary, DAZ appears to be a potential new therapy for SjD and its efficacy implies an important role for the CD40/CD40 ligand pathway in its pathogenesis. ClinicalTrials.gov identifier: NCT04129164 .
- | dazodalibep (HZN-4920) / Amgen
Enrollment open, Phase classification: VIBRANT: VIB4920 for Active Lupus Nephritis (clinicaltrials.gov) - Jun 6, 2024
P2, N=74, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov identifier: NCT04129164 . Active, not recruiting --> Recruiting | Phase classification: P2a --> P2
- |||| dazodalibep (HZN-4920) / Amgen
Trial primary completion date: A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj (clinicaltrials.gov) - May 29, 2024
P3, N=510, Recruiting, Sponsor: Amgen
Active, not recruiting --> Recruiting | Phase classification: P2a --> P2 Trial primary completion date: Feb 2026 --> Jul 2026
- dazodalibep (HZN-4920) / Amgen
CD40L BLOCKADE WITH DAZODALIBEP SIGNIFICANTLY IMPROVES DISEASE ACTIVITY, SWOLLEN AND TENDER JOINT COUNTS, WHILE REDUCING MULTIPLE T- AND B-CELL BIOMARKERS IN THE MIDORA PHASE 2 STUDY OF PATIENTS WITH MODERATE-TO-SEVERE ACTIVE RHEUMATOID ARTHRITIS () - May 29, 2024 - Abstract #EULAR2024EULAR_3431;
P2
Additionally, DAZ reduced biomarkers of T- and B-cell costimulatory blockade, and inhibition of GC formation activity, and autoantibody production. Together, these data demonstrate the biological impact of CD40-CD40L pathway blockade on selected blood biomarkers in RA.
- |||||| dazodalibep (HZN-4920) / Amgen
Enrollment open: HZNP-DAZ-303: A Safety and Efficacy Study of Dazodalibep in Participants With Sj (clinicaltrials.gov) - Apr 2, 2024
P3, N=435, Recruiting, Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
Together, these data demonstrate the biological impact of CD40-CD40L pathway blockade on selected blood biomarkers in RA. Not yet recruiting --> Recruiting
- dazodalibep (HZN-4920) / Amgen
DAZODALIBEP (ANTI-CD40L) EFFECTIVELY REDUCES MULTIPLE PROTEINS ASSOCIATED WITH B-, T-, AND DENDRITIC CELL BIOMARKERS IN SJ?GREN'S DISEASE: CORROBORATION OF IMMUNOPHENOTYPING FINDINGS FROM THE ALISS PHASE 2 STUDY (C7) - Mar 29, 2024 - Abstract #EULAR2024EULAR_922;
P2
Importantly, these biomarkers were shown to be significantly reduced by DAZ. These proteomics findings corroborate previous immunophenotyping flow cytometry data from the ALISS phase 2 study that demonstrated significant reductions of B and T cell activation and proliferation by DAZ in subjects with Sjogren's disease across populations with either moderate-to-severe disease activity or high symptomatic burden.
- |||||||||| dazodalibep (HZN-4920) / Amgen
New P3 trial: HZNP-DAZ-303: A Safety and Efficacy Study of Dazodalibep in Participants With Sj (clinicaltrials.gov) - Feb 15, 2024
P3, N=435, Not yet recruiting, Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
- | dazodalibep (HZN-4920) / Amgen
Enrollment closed: CONTROL-RA: CD40L Antagonism in Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Jan 31, 2024
P2, N=104, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
These proteomics findings corroborate previous immunophenotyping flow cytometry data from the ALISS phase 2 study that demonstrated significant reductions of B and T cell activation and proliferation by DAZ in subjects with Sjogren's disease across populations with either moderate-to-severe disease activity or high symptomatic burden. Not yet recruiting --> Active, not recruiting
- |||||| dazodalibep (HZN-4920) / Amgen
Enrollment open: A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj (clinicaltrials.gov) - Dec 21, 2023
P3, N=510, Recruiting, Sponsor: Horizon Therapeutics Ireland DAC
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || dazodalibep (HZN-4920) / Amgen
P2 data, Journal: Correction: The MIDORA trial: a phase II, randomised, double-blind, placebo-controlled, mechanistic insight and dosage optimisation study of the efficacy and safety of dazodalibep in patients with rheumatoid arthritis. (Pubmed Central) - Dec 20, 2023
Not yet recruiting --> Recruiting No abstract available
- |||||||||| dazodalibep (HZN-4920) / Amgen
New P3 trial: A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj (clinicaltrials.gov) - Oct 27, 2023
P3, N=510, Not yet recruiting, Sponsor: Horizon Therapeutics Ireland DAC
- dazodalibep (HZN-4920) / Amgen
Dazodalibep, a CD40L Antagonist, in a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Trial of Subjects with Sj (Poster Hall; In Person) - Oct 24, 2023 - Abstract #ACRConvergence2023ACR_Convergence_4576;
P2
No abstract available The results during Stage II provide further evidence of the clinical efficacy of DAZ in Sj
- | dazodalibep (HZN-4920) / Amgen
Enrollment closed, Enrollment change: VIBRANT: VIB4920 for Active Lupus Nephritis (clinicaltrials.gov) - Oct 16, 2023
P2a, N=74, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
The results during Stage II provide further evidence of the clinical efficacy of DAZ in Sj Recruiting --> Active, not recruiting | N=114 --> 74
- dazodalibep (HZN-4920) / Amgen
Population Pharmacokinetic/Pharmacodynamic Modeling of Dazodalibep, a CD40L Antagonist, in Healthy Volunteers and Patients with Rheumatoid Arthritis and Sjogren (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3467;
The PK and PK/PD of DAZ were successfully described by population modeling. The modeling results supported the selection of dose to be further evaluated in upcoming phase 3 studies.
- dazodalibep (HZN-4920) / Amgen
CD40L Inhibition with Dazodalibep Rapidly Reduces Blood Biomarkers of T and B Cell Costimulation in Subjects with Sj (Room 5A-B; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1832;
P2
The modeling results supported the selection of dose to be further evaluated in upcoming phase 3 studies. DAZ-mediated CD40-CD40L blockade in subjects with Sj
- dazodalibep (HZN-4920) / Amgen
Dazodalibep, a CD40L Antagonist, in Subjects with Sj (Room 5A-B; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_1830;
P2
DAZ-mediated CD40-CD40L blockade in subjects with Sj The results during Stage II provide further evidence of DAZ clinical efficacy in Sj
- || dazodalibep (HZN-4920) / Horizon Therapeutics
P2 data, Journal: The MIDORA trial: a phase II, randomised, double-blind, placebo-controlled, mechanistic insight and dosage optimisation study of the efficacy and safety of dazodalibep in patients with rheumatoid arthritis. (Pubmed Central) - Aug 9, 2023
P2
The safety data suggest an acceptable safety and tolerability profile. Treatment effects at day 113 and the prolonged duration of responses after DAZ cessation support the use of longer dosing intervals.
- | dazodalibep (HZN-4920) / Horizon Therapeutics
✍️Dazodalibep en #Sjögren Bien tolerado en ECA de Fase 2 ➡️rumbo a la fase 3. Deseando🙏💪💪 resultado positivo LB0003 #SSj ⬇️ Thanks for sharing @Janetbirdope (Twitter) - Jun 21, 2023
- ||| dazodalibep (HZN-4920) / Horizon Therapeutics
P3 data: Thank you for this update. I suffer from Sjogrens. Do you think phase 3 of dazodalibep will be done in 1-2 years, and do you think that the common person will be able to afford it? (Twitter) - Jun 15, 2023
- || Tai'ai (telitacicept) / Rongchang Pharma, dazodalibep (HZN-4920) / Horizon Therapeutics
how expensive could dazodalibep or telitacicept going to be ? Will it be affordable to the common person? Thank you for giving us hope with your writing. (Twitter) - Jun 15, 2023
- |||| dazodalibep (HZN-4920) / Horizon Therapeutics, frexalimab (SAR441344) / Sanofi
Clinical: Thanks for sharing. Is this similar to #dazodalibep being trialled for #Sjogren’s disease (another progressive disease w EBV as a potential trigger & a huge under-recognised neuro component (autonomic, SFN, PN,LFN,CNS)? Could frexalimab potentially be effective in #Sjogren’s too? (Twitter) - Jun 1, 2023
- ||| dazodalibep (HZN-4920) / Amgen
Trial completion: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sj (clinicaltrials.gov) - Mar 29, 2023
P2, N=183, Completed, Sponsor: Viela Bio (acquired by Horizon Therapeutics)
Treatment effects at day 113 and the prolonged duration of responses after DAZ cessation support the use of longer dosing intervals. Active, not recruiting --> Completed
- || dazodalibep (HZN-4920) / Amgen
Trial completion: A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant (clinicaltrials.gov) - Mar 28, 2023
P2a, N=20, Completed, Sponsor: Viela Bio (acquired by Horizon Therapeutics)
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | dazodalibep (HZN-4920) / Amgen
Enrollment open: CONTROL-RA: CD40L Antagonism in Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Mar 22, 2023
P2, N=104, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- |||||| dazodalibep (HZN-4920) / Horizon Therapeutics
Clinical, P2 data, P3 data: What to do next? Dazodalibep Rx in bDMARDs IR #RA pts. Dazo is a novel CD40 ligand antagonist Phase II RCT. N=78, multi dose phase II RCT. All doses improved DAS28. Dosing interval may be prolonged over time. Awaiting phase 3. Abst#2008 #ACR22 @RheumNow (Twitter) - Nov 13, 2022
- | lorecivivint (SM04690) / Biosplice Therap, Samil Pharma, dazodalibep (HZN-4920) / Horizon Therapeutics, lenabasum (JBT-101) / Corbus Pharma, Kaken Pharma
#ACR22 #ACRambassador Abstracts: Whats in the future? @anzypanzywanzy @KarlasRheum @rheum4you . 1894: Lorecivivint: https://t.co/Tjey2ccRb7 . 0371: Lenabasum: https://t.co/qNmyZcI5Sd 2008: Dazodalibep: https://t.co/3nXyyN811j (Twitter) - Nov 6, 2022
- | dazodalibep (HZN-4920) / Amgen
Trial initiation date: CONTROL-RA: CD40L Antagonism in Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Oct 28, 2022
P2, N=104, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Not yet recruiting --> Recruiting Initiation date: Aug 2022 --> Dec 2022
- dazodalibep (HZN-4920) / Horizon Therapeutics
A Phase 2a Trial of VIB4920 for Active Lupus Nephritis (VIBRANT) (Exhibit Hall, Orange County Convention Center, West Building) - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_4543;
P2a
Enrollment May 2022-2025 . Additional information: http://www.vibrant-study.org/
- dazodalibep (HZN-4920) / Horizon Therapeutics
A Phase 2a Trial of VIB4920 for Active Lupus Nephritis (VIBRANT) (Exhibit Hall, Orange County Convention Center, West Building) - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_3891;
P2a
Enrollment May 2022-2025 . Additional information: http://www.vibrant-study.org/
- dazodalibep (HZN-4920) / Horizon Therapeutics
A Phase 2a Trial of VIB4920 for Active Lupus Nephritis (VIBRANT) (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_858;
P2a
Enrollment May 2022-2025 . Additional information: http://www.vibrant-study.org/
- dazodalibep (HZN-4920) / Horizon Therapeutics
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Patients with Rheumatoid Arthritis Having Inadequate Response to Conventional/Biological DMARDs (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1876;
P2
DAZ reduced DAS28-CRP and RF significantly vs. PBO at d113 in all dose regimens. Safety and tolerability were consistent with previous observations.
- dazodalibep (HZN-4920) / Horizon Therapeutics
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of Dazodalibep (VIB4920/HZN4920) in Patients with Rheumatoid Arthritis Having Inadequate Response to Conventional/Biological DMARDs (Center City Stage) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_1443;
P2
DAZ reduced DAS28-CRP and RF significantly vs. PBO at d113 in all dose regimens. Safety and tolerability were consistent with previous observations.
- || dazodalibep (HZN-4920) / Amgen
Enrollment closed, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sj (clinicaltrials.gov) - Sep 14, 2022
P2, N=183, Active, not recruiting, Sponsor: Viela Bio (acquired by Horizon Therapeutics)
Safety and tolerability were consistent with previous observations. Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Sep 2022
- | dazodalibep (HZN-4920) / Amgen
Trial initiation date: CONTROL-RA: CD40L Antagonism in Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Jun 22, 2022
P2, N=104, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2023 --> Sep 2022 Initiation date: May 2022 --> Aug 2022
- | dazodalibep (HZN-4920) / Amgen
Enrollment open: VIBRANT: VIB4920 for Active Lupus Nephritis (clinicaltrials.gov) - Jun 8, 2022
P2a, N=114, Recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Initiation date: May 2022 --> Aug 2022 Not yet recruiting --> Recruiting
- ||| dazodalibep (VIB4920) / Horizon Therapeutics
Topline Data for Dazodalibep (HZN-4920) Meets Primary Endpoint in Rheumatoid Arthritis https://t.co/ZgIy1Hg9dU (Twitter) - May 3, 2022
- | Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen, dazodalibep (HZN-4920) / Amgen
Enrollment change, Trial withdrawal: Safety and Tolerability of Inebilizumab, VIB4920, or the Combination in Highly Sensitized Candidates Awaiting Kidney Transplantation From a Deceased Donor (clinicaltrials.gov) - Apr 22, 2022
P2, N=0, Withdrawn, Sponsor: Viela Bio
Not yet recruiting --> Recruiting N=36 --> 0 | Suspended --> Withdrawn
- | dazodalibep (HZN-4920) / Amgen
Trial initiation date: VIBRANT: VIB4920 for Active Lupus Nephritis (clinicaltrials.gov) - Apr 14, 2022
P2a, N=114, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=36 --> 0 | Suspended --> Withdrawn Initiation date: Feb 2022 --> Jun 2022
- | dazodalibep (HZN-4920) / Amgen
New P2 trial: CONTROL-RA: CD40L Antagonism in Rheumatoid Arthritis (RA) (clinicaltrials.gov) - Apr 1, 2022
P2, N=104, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- ||| dazodalibep (HZN-4920) / Amgen
Trial completion: MIDORA: A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - Feb 16, 2022
P2, N=78, Completed, Sponsor: Viela Bio
Initiation date: Feb 2022 --> Jun 2022 Active, not recruiting --> Completed
- | dazodalibep (HZN-4920) / Amgen
New P2a trial: VIBRANT: VIB4920 for Active Lupus Nephritis (clinicaltrials.gov) - Jan 20, 2022
P2a, N=114, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- || dazodalibep (HZN-4920) / Amgen
Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sj (clinicaltrials.gov) - Oct 1, 2021
P2, N=174, Recruiting, Sponsor: Viela Bio
Active, not recruiting --> Completed Trial completion date: Apr 2022 --> Jun 2023 | Trial primary completion date: Nov 2021 --> Feb 2023
- || dazodalibep (HZN-4920) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date: MIDORA: A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis (clinicaltrials.gov) - Sep 23, 2021
P2, N=78, Active, not recruiting, Sponsor: Viela Bio
Trial completion date: Apr 2022 --> Jun 2023 | Trial primary completion date: Nov 2021 --> Feb 2023 Recruiting --> Active, not recruiting | Trial completion date: Jul 2021 --> Dec 2021 | Trial primary completion date: Jul 2021 --> Dec 2021