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Journal Articles

Pharmacokinetic Characterization and Exposure-Response Relationship of Crovalimab in the COMPOSER and COMMODORE 3 Trials of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Simon Buatois, Khaled Benkali, Andrea Henrich, Félix Jaminion, Yuchen Zhang, Alexandre Sostelly

Blood (2022) 140 (Supplement 1): 2918–2920.

https://doi.org/10.1182/blood-2022-158244

Published: 2022

Journal Articles

Two Currently Recruiting Randomized Phase III Trials: COMMODORE 1 and 2 Evaluating Crovalimab Vs Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria with or without Current Anti-Complement Therapy

Austin G. Kulasekararaj, Antonio Risitano, Alexander Roeth, Guangsheng He, Jeffrey Pu, Lilyan Wright, Anita Appius, Alexandre Sostelly, Sasha Sreckovic, Sven F Stanzel, Talha Munir, Jun-Ichi Nishimura

Blood (2021) 138 (Supplement 1): 4313.

https://doi.org/10.1182/blood-2021-152306

Published: 2021

Journal Articles

Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase IIa CROSSWALK-c Trial Evaluating the Efficacy of Crovalimab As Adjunct Treatment in the Prevention of Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD)

Michael Callaghan, Kenneth I. Ataga, Lucia De Franceschi, Caterina Minniti, Nadiesh Balachandran, Diane-Charlotte Imbs, Thomas Perretti, Julia Ramos, Alexandre Sostelly, Pablo Bartolucci

Blood (2021) 138 (Supplement 1): 3111.

https://doi.org/10.1182/blood-2021-151222

Published: 2021

Journal Articles

Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase Ib CROSSWALK-a Trial Evaluating the Safety of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD)

Pablo Bartolucci, Kenneth I. Ataga, Michael U. Callaghan, Lucia De Franceschi, Caterina Minniti, Ari Alexandrou, Diane-Charlotte Imbs, Richard Fox, Himika Patel, Alexandre Sostelly, Jonathan Schimmel

Blood (2021) 138 (Supplement 1): 3108.

https://doi.org/10.1182/blood-2021-147854

Published: 2021

Journal Articles

An Optimized Crovalimab Dose and Regimen Reduced the Formation of Drug-Target-Drug Complexes in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Phase I/II COMPOSER Trial

Blood (2020) 136 (Supplement 1): 2–3.

https://doi.org/10.1182/blood-2020-136265

Published: 2020

Journal Articles

Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 1 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with Complement Inhibitors

Antonio Risitano, Alexander Röth, MD, Austin Kulasekararaj, MDMBBS,MRCP,FRCPath, Jeffrey Pu, MDPhD, Jun-ichi Nishimura, MD PhD, Lilyan Wright, PhD, Anita Appius, PhD, Alexandre Sostelly, PhD, Sasha Sreckovic, MD, Charlotte Vignal, PhD, Talha Munir, MBBS

Blood (2020) 136 (Supplement 1): 43–44.

https://doi.org/10.1182/blood-2020-137471

Published: 2020

Journal Articles

Population Pharmacokinetic/Pharmacodynamic Modelling from the Phase I/II COMPOSER Trial to Predict Lowering of Lactate Dehydrogenase in Crovalimab-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria

Simon Buatois, PharmD, PhD, Alexandre Sostelly, PhD, Antoine Soubret, PhD, Felix Jaminion, Valerie Cosson, PhD

Blood (2020) 136 (Supplement 1): 9–10.

https://doi.org/10.1182/blood-2020-134590

Published: 2020

Journal Articles

Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 2 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Not Previously Treated with Complement Inhibitors

Austin Kulasekararaj, MDMBBS,MRCP,FRCPath, Guangsheng He, MD PhD, Talha Munir, MBBS, Jeffrey Pu, MDPhD, Antonio Risitano, Alexander Röth, MD, Camelia S. Sima, MD, Anita Appius, PhD, Alexandre Sostelly, PhD, Sasha Sreckovic, MD, Charlotte Vignal, PhD, Jun-Ichi Nishimura, MD PhD

Blood (2020) 136 (Supplement 1): 34.

https://doi.org/10.1182/blood-2020-136647

Published: 2020

Journal Articles

Crovalimab for Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria and Complement C5 Polymorphism - Experience from the Phase I/II COMPOSER Study

Jun-ichi Nishimura, MD PhD, Kensuke Usuki, MD PhD, Julia Ramos, MD PhD, Satoshi Ichikawa, MD PhD, Jules Hernández-Sánchez, PhD, Anna Kiialainen, PhD, Alexandre Sostelly, PhD, Regis Peffault De Latour, MD PhD, Ido Paz-Priel, MD, Alexander Röth, MD

Blood (2020) 136 (Supplement 1): 5–6.

https://doi.org/10.1182/blood-2020-136048

Published: 2020

Journal Articles

COMPOSER Part 4: An Optimized Dosing Strategy for Crovalimab in the Treatment of Complement Inhibitor-Naïve or -Experienced Patients with Paroxysmal Nocturnal Hemoglobinuria

Regis Peffault De Latour, MD PhD, Simona Sica, MD PhD, Julia Ramos, MD, Jules Hernández-Sánchez, PhD, Jin Seok Kim, MD PhD, Anna Kiialainen, PhD, Sung-Soo Yoon, MD PhD, Sasha Sreckovic, MD, Antoine Soubret, PhD, Haruhiko Ninomiya, MD PhD, Alexandre Sostelly, PhD, Jens Panse, MD, Simon Buatois, PharmD, PhD, Hubert Schrezenmeier, Ido Paz-Priel, MD, Jun-ichi Nishimura, MD PhD, Alexander Röth, MD

Blood (2020) 136 (Supplement 1): 6–7.

https://doi.org/10.1182/blood-2020-135841

Published: 2020

Journal Articles

The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria

Blood (2020) 135 (12): 912–920.

https://doi.org/10.1182/blood.2019003399

Published: 2020

Includes: Supplemental data

Journal Articles

Characterizing C5 Inhibition with the SMART-Ig Anti-hC5 Antibody Crovalimab in PNH Patients Using Free Available Paratopes

Alexandre Sostelly, M.Eng., PhD, Antoine Soubret, Christoph Bucher, MD, Simon Buatois, Jean-Eric Charoin, Gregor Jordan, Barbara Klughammer, PhD, Andreas Dieckmann, Taku Fukuzawa, PhD, Keisuke Gotanda, Kenji Shinomiya, Sung-Soo Yoon, MD PhD, Jens P. Panse, Junichi Nishimura, MD PhD, Alexander Röth, MD PhD, Zsolt Nagy, MD PhD, Régis Peffault de Latour, MD PhD

Blood (2019) 134 (Supplement_1): 1227.

https://doi.org/10.1182/blood-2019-126911

Published: 2019

Journal Articles

Exposure-Response Relationship of the SMART-Ig Anti-hC5 Antibody Crovalimab (SKY59): Results from the Umbrella Phase 1/2 Composer Trial in Healthy Volunteers and PNH Patients

Alexandre Sostelly, M.Eng., PhD, Simon Buatois, Antoine Soubret, Erica Winter, PharmD, Barbara Klughammer, PhD, Joy C. Hsu, Gregor Jordan, Christoph Bucher, MD, Jean-Eric Charoin, Keisuke Gotanda, Kenji Shinomiya, Zsolt Nagy, MD PhD, Jens P. Panse, Sung-Soo Yoon, MD PhD, Régis Peffault de Latour, MD PhD, Junichi Nishimura, MD PhD, Alexander Röth, MD PhD

Blood (2019) 134 (Supplement_1): 3745.

https://doi.org/10.1182/blood-2019-124258

Published: 2019

NARROW

Pharmacokinetic Characterization and Exposure-Response Relationship of Crovalimab in the COMPOSER and COMMODORE 3 Trials of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Two Currently Recruiting Randomized Phase III Trials: COMMODORE 1 and 2 Evaluating Crovalimab Vs Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria with or without Current Anti-Complement Therapy

Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase IIa CROSSWALK-c Trial Evaluating the Efficacy of Crovalimab As Adjunct Treatment in the Prevention of Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD)

Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase Ib CROSSWALK-a Trial Evaluating the Safety of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD)

An Optimized Crovalimab Dose and Regimen Reduced the Formation of Drug-Target-Drug Complexes in Patients with Paroxysmal Nocturnal Hemoglobinuria from the Phase I/II COMPOSER Trial

Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 1 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with Complement Inhibitors

Population Pharmacokinetic/Pharmacodynamic Modelling from the Phase I/II COMPOSER Trial to Predict Lowering of Lactate Dehydrogenase in Crovalimab-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria

Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 2 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Not Previously Treated with Complement Inhibitors

Crovalimab for Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria and Complement C5 Polymorphism - Experience from the Phase I/II COMPOSER Study

COMPOSER Part 4: An Optimized Dosing Strategy for Crovalimab in the Treatment of Complement Inhibitor-Naïve or -Experienced Patients with Paroxysmal Nocturnal Hemoglobinuria

The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria

Characterizing C5 Inhibition with the SMART-Ig Anti-hC5 Antibody Crovalimab in PNH Patients Using Free Available Paratopes

Exposure-Response Relationship of the SMART-Ig Anti-hC5 Antibody Crovalimab (SKY59): Results from the Umbrella Phase 1/2 Composer Trial in Healthy Volunteers and PNH Patients

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American Society of Hematology

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ASH Publications

American Society of Hematology

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