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4 Diseases |  |
3 Trials |
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3 Trials |  |
55 News |  |
- The True Value of Living Systematic Reviews (LSRs): A Case Report Within Systemic Lupus Erythematosus (SLE) () - Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_316;
An SLR search update 16 months after the primary search generated 18 new publications, providing a significant addition to the available evidence on current therapy options. The update provides insight into the appropriate cadence for LSRs and highlights efficiencies gained with LiveSLRTM.
- |||||||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
New P3 trial: PHOENYCS FLY: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Sep 26, 2024
P3, N=450, Not yet recruiting, Sponsor: UCB Biopharma SRL
- ||||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion, Trial completion date: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Jul 4, 2024
P3, N=321, Completed, Sponsor: UCB Biopharma SRL
The update provides insight into the appropriate cadence for LSRs and highlights efficiencies gained with LiveSLRTM. Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Jun 2024
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial primary completion date: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Jun 21, 2024
P3, N=321, Active, not recruiting, Sponsor: UCB Biopharma SRL
Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> Jun 2024 Trial primary completion date: Sep 2024 --> May 2024
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
DAPIROLIZUMAB PEGOL IMPACTS IMPORTANT IMMUNOLOGIC PATHWAYS IN SYSTEMIC LUPUS ERYTHEMATOSUS: PHARMACODYNAMIC ANALYSIS OF B CELL AND TYPE I INTERFERON PATHWAYS FROM A PHASE 2B TRIAL (Poster Tour 5) - Mar 29, 2024 - Abstract #EULAR2024EULAR_2166;
P2, P3
DZP also decreases expression of type I IFN signatures in pts with high baseline type I IFN expression. The impacts of DZP were seen as early as Wk 2 following a single dose.
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
DAPIROLIZUMAB PEGOL IMPACTS IMPORTANT IMMUNOLOGIC PATHWAYS IN SYSTEMIC LUPUS ERYTHEMATOSUS: PHARMACODYNAMIC ANALYSIS OF T CELL AND ANTIGEN PRESENTING CELL PATHWAYS FROM A PHASE 2B TRIAL (Poster Tour 5) - Mar 29, 2024 - Abstract #EULAR2024EULAR_2160;
P2, P3
Beyond its known effects on B cells and IFN signaling,[8] these data demonstrate targeted effects of DZP on T cell activation and additional proinflammatory cytokines, such as IFN-?, involved in T cell activation and adaptive immune responses related to SLE. The identified biomarkers will undergo further validation in planned pharmacodynamic studies in relation to clinical efficacy.
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Dapirolizumab Pegol Impacts Important Immunologic Pathways in SLE: Pharmacodynamic Analysis of B Cell and Type I Interferon Pathways from a Phase 2b Trial (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_4308;
P2, P3
Moreover, DZP decreases expression of type I IFN signatures in pts with high baseline type I IFN expression. The impacts of DZP were seen as early as Wk 2.
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Dapirolizumab Pegol Efficacy by Subgroups in Patients with SLE: A Post Hoc Analysis of Phase 2b Clinical Trial Data (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_4307;
P2
Albeit in a limited sample size, pts with acute flare and normal complement were more likely to achieve response to SOC+PBO than pts with acute flare and low complement or persistent disease activity. These data suggest that SLE trial design may need to consider baseline clinical and serologic activity patterns to adequately assess treatment efficacy.
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap, Epratucyn (epratuzumab) / Gilead
Disease Course and Complement as Predictors of Response to Standard of Care Plus Placebo in Patients with SLE: A Post Hoc Analysis of Dapirolizumab Pegol and Epratuzumab Clinical Trial Data (Poster Hall; in person) - Sep 23, 2023 - Abstract #ACRConvergence2023ACR_Convergence_3565;
P2, P3
In RISE, normal complement levels also predicted SOC+PBO response; low complement has been described as a predictor of increased treatment effect in previous studies. 5 Recent medical history of pts may have to be considered when defining SLE study populations.
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion date, Trial primary completion date: A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus (clinicaltrials.gov) - Jul 28, 2023
P3, N=760, Enrolling by invitation, Sponsor: UCB Biopharma SRL
5 Recent medical history of pts may have to be considered when defining SLE study populations. Trial completion date: Sep 2029 --> Apr 2029 | Trial primary completion date: Sep 2029 --> Apr 2029
- ||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Enrollment closed: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Jul 14, 2023
P3, N=312, Active, not recruiting, Sponsor: UCB Biopharma SRL
Trial completion date: Sep 2029 --> Apr 2029 | Trial primary completion date: Sep 2029 --> Apr 2029 Recruiting --> Active, not recruiting
- || Review, Journal: Cutaneous Lupus Erythematosus: An Update on Pathogenesis and Future Therapeutic Directions. (Pubmed Central) - May 4, 2023
Moreover, Janus kinase (JAK) and spleen tyrosine kinase (SYK) inhibitors might broaden the therapeutic armamentarium in the near future. A close interdisciplinary exchange with rheumatologists and nephrologists is mandatory for optimal treatment of lupus patients to define the best therapeutic strategy.
- ||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Enrollment change, Trial completion date, Trial primary completion date: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Apr 18, 2023
P3, N=312, Recruiting, Sponsor: UCB Biopharma SRL
A close interdisciplinary exchange with rheumatologists and nephrologists is mandatory for optimal treatment of lupus patients to define the best therapeutic strategy. N=450 --> 312 | Trial completion date: Aug 2025 --> Sep 2024 | Trial primary completion date: Aug 2025 --> Sep 2024
- || dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
P2b data, PK/PD data, Journal: Population Pharmacokinetics and Exposure-Response for Dapirolizumab Pegol From a Phase 2b Trial in Patients With Systemic Lupus Erythematosus. (Pubmed Central) - Mar 14, 2023
P2
Notably, the half maximal effective concentration (EC ) was greater for the transition from "Responder" to "Non-Responder" (150 ?g/mL) than the transition from "Non-Responder" to "Responder" (12 ?g/mL), indicating that sustained dapirolizumab pegol concentrations may be required to maintain BICLA response. In conclusion, dapirolizumab pegol pharmacokinetics were as expected for a PEGylated molecule and results from the exposure-response model indicate that a favorable dapirolizumab pegol effect was identified for both BICLA "Non-Responder" to "Responder" and "Responder" to "Non-Responder" transition probabilities.
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion date, Trial primary completion date: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Sep 21, 2022
P3, N=450, Recruiting, Sponsor: UCB Biopharma SRL
In conclusion, dapirolizumab pegol pharmacokinetics were as expected for a PEGylated molecule and results from the exposure-response model indicate that a favorable dapirolizumab pegol effect was identified for both BICLA "Non-Responder" to "Responder" and "Responder" to "Non-Responder" transition probabilities. Trial completion date: Apr 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Aug 2025
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion date, Trial primary completion date: A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus (clinicaltrials.gov) - Sep 10, 2022
P3, N=760, Enrolling by invitation, Sponsor: UCB Biopharma SRL
Trial completion date: Apr 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Aug 2025 Trial completion date: Dec 2026 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Sep 2029
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion date, Trial primary completion date: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Mar 16, 2022
P3, N=450, Recruiting, Sponsor: UCB Biopharma SRL
Trial completion date: Dec 2026 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Sep 2029 Trial completion date: Nov 2023 --> Apr 2024 | Trial primary completion date: Sep 2023 --> Mar 2024
- |||||||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
New P3 trial: A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus Estudio para evaluar la eficacia y la seguridad del dapirolizumab pegol en participantes en el estudio con lupus eritematoso sist (EUDRACT) - Feb 15, 2022
P3, N=450, , Sponsor: UCB Biopharma SRL
- || dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Clinical, P2 data, Journal: Phase 2, Randomized, Placebo-Controlled Trial of Dapirolizumab Pegol in Patients with Moderate-to-Severe Active Systemic Lupus Erythematosus. (Pubmed Central) - Dec 28, 2021
Although the primary objective was not met, DZP appeared to be well tolerated, and patients exhibited improvements across multiple clinical and immunological measures of disease activity after 24 weeks relative to placebo. The potential clinical benefit of DZP warrants further investigation.
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion date, Trial primary completion date: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Aug 23, 2021
P3, N=450, Recruiting, Sponsor: UCB Biopharma SRL
The potential clinical benefit of DZP warrants further investigation. Trial completion date: Apr 2023 --> Nov 2023 | Trial primary completion date: Feb 2023 --> Sep 2023
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
[VIRTUAL] PHARMACODYNAMIC EFFECTS ON IMMUNOGLOBULINS FOLLOWING DAPIROLIZUMAB PEGOL TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS (Hall 2) - Aug 21, 2021 - Abstract #LUPUS2021LUPUS_478;
P2
SOC+DZP (24 or 45mg/kg Q4W) reduced serum Ig levels and downregulated Ig gene expression in SLE patients. This supports previous findings.
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion date, Trial primary completion date: A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus (clinicaltrials.gov) - Aug 18, 2021
P3, N=760, Enrolling by invitation, Sponsor: UCB Biopharma SRL
This supports previous findings. Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026
- |||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Enrollment open: A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus (clinicaltrials.gov) - Jul 28, 2021
P3, N=760, Enrolling by invitation, Sponsor: UCB Biopharma SRL
Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026 Not yet recruiting --> Enrolling by invitation
- |||||||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
New P3 trial: A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus (clinicaltrials.gov) - Jul 26, 2021
P3, N=760, Not yet recruiting, Sponsor: UCB Biopharma SRL
- || dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants (clinicaltrials.gov) - Apr 29, 2021
P1, N=33, Completed, Sponsor: Biogen
Not yet recruiting --> Enrolling by invitation Recruiting --> Completed
- || dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Enrollment open: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants (clinicaltrials.gov) - Dec 11, 2020
P1, N=32, Recruiting, Sponsor: Biogen
Recruiting --> Completed Not yet recruiting --> Recruiting
- |||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion date, Trial primary completion date: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 4, 2020
P3, N=450, Recruiting, Sponsor: UCB Biopharma SRL
Not yet recruiting --> Recruiting Trial completion date: Nov 2022 --> Apr 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
- || dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
New P1 trial: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB133 (Dapirolizumab Pegol) in Healthy Japanese and Caucasian Participants (clinicaltrials.gov) - Sep 30, 2020
P1, N=32, Not yet recruiting, Sponsor: Biogen
- |||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Enrollment open: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Aug 19, 2020
P3, N=450, Recruiting, Sponsor: UCB Biopharma SRL
Trial completion date: Nov 2022 --> Apr 2023 | Trial primary completion date: Oct 2022 --> Feb 2023 Not yet recruiting --> Recruiting
- |||||||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
New P3 trial: PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - Mar 4, 2020
P3, N=450, Not yet recruiting, Sponsor: UCB Biopharma SRL
- || Rituxan (rituximab) / Roche, Biogen
Clinical, Journal: Recent developments in biologic therapies for the treatment of patients with systemic lupus erythematosus. (Pubmed Central) - Jan 11, 2020
In this review, we consider newer biologic approaches that might offer the hope of improving the outcome of SLE patients. These include the fully humanized anti-CD20 mAbs, PEGylated anti-CD40L, IFNα inhibitors, rigerimod and immune complexes blockade.
- ||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therapeutics
Dapirolizumab pegol for moderately to severely active #Lupus #ACR19 (Twitter) - Nov 10, 2019
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therapeutics
Efficacy and Safety of Dapirolizumab Pegol in Patients with Moderately to Severely Active Systemic Lupus Erythematosus: A Randomized, Placebo-Controlled Study (A411-A412) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_1950;
P2
Upon study drug withdrawal, immunologic parameters returned to baseline levels, whilst clinical outcomes such as SLEDAI and PGA stabilized. None of the prespecified dose-response models could be selected; thus, the primary endpoint was not met.
- || dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therapeutics
If $AZN can do it - What can't we : $BIIB $UCB Dapirolizumab says "None of the prespecified dose-response models could be selected; thus, the primary endpoint was not met" - BUT, we'll move to Pivotal anyways #ACR2019 (Twitter) - Oct 1, 2019
- ||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion: A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus (clinicaltrials.gov) - Jan 29, 2019
P2, N=182, Completed, Sponsor: UCB Biopharma S.P.R.L.
None of the prespecified dose-response models could be selected; thus, the primary endpoint was not met. Active, not recruiting --> Completed
- ||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Enrollment closed: A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus (clinicaltrials.gov) - Dec 18, 2017
P2, N=182, Active, not recruiting, Sponsor: UCB Biopharma S.P.R.L.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial primary completion date: A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus (clinicaltrials.gov) - Nov 13, 2017
P2, N=160, Recruiting, Sponsor: UCB Biopharma S.P.R.L.
Recruiting --> Active, not recruiting Trial primary completion date: Mar 2018 --> Jun 2018
- ||||| dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
New P2 trial: A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus (clinicaltrials.gov) - Jun 18, 2016
P2, N=160, Recruiting, Sponsor: UCB Biopharma S.P.R.L.
- | dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion: Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Aug 27, 2014
P1, N=24, Completed, Sponsor: UCB, Inc.
Trial primary completion date: Mar 2018 --> Jun 2018 Active, not recruiting --> Completed
- dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Enrollment closed: Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Feb 19, 2014
P1, N=24, Active, not recruiting, Sponsor: UCB, Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
New P1 trial: Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - Jan 7, 2013
P1, N=24, Active, not recruiting, Sponsor: UCB, Inc.
- | dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap
Trial completion: Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Jan 2, 2013
P1, N=44, Completed, Sponsor: UCB, Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed