riliprubart (SAR445088) / Sanofi - LARVOL DELTA

MOBILIZE: A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work (clinicaltrials.gov) - P3 | N=109 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2028 ➔ Oct 2027 | Trial primary completion date: May 2027 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date

Riliprubart in CIDP: Time and Magnitude of Response Analysis from a Phase 2 Trial (ICNMD 2026) - P2 | "Riliprubart provided rapid and substantial improvement i n INCAT score with majority of responders achieving first response by Week - 12 and nearly half of responders achieving deep response ( ≥2-point decrease); supporting Phase-3 development of riliprubart as a potential treatment for people with CIDP ."

P2 data

Riliprubart Phase 2 Trial Results: Efficacy Analysis Using Immune Neuropathy-No Evidence of Disease Activity Framework (ICNMD 2026) - P2 | "These results will help illustrate the applicability of the IN-NEDA framework in CIDP, supporting its role as a comprehensive approach for assessing sustained disease control."

Clinical • P2 data • CNS Disorders • Multiple Sclerosis

Phase 2 Trial of Riliprubart in CIDP: Patient-reported Quality-of-life, Pain and Fatigue Outcomes at Week-76 (ICNMD 2026) - P2 | "Riliprubart indicated sustained decrease in fatigue and pain, and improved QoL in people with CIDP, along with clinical improvement. Two randomized, placebo-controlled Phase-3 studies(MOBILIZE, VITALIZE) are ongoing to confirm these findings."

Clinical • HEOR • P2 data • Fatigue • Pain

Riliprubart in CIDP: Time and Magnitude of Response Analysis from a Phase 2 Trial (EAN 2026) - P2 | "Riliprubart provided rapid and substantial improvement in INCAT score with majority of responders achieving first response by Week-12 and nearly half of responders achieving deep response (≥2-point decrease); supporting Phase-3 development of riliprubart as a potential treatment for people with CIDP."

P2 data

Phase 2 Trial of Riliprubart in CIDP: Patient-reported Quality-of-life, Pain and Fatigue Outcomes at Week-76 (EAN 2026) - P2 | "Riliprubart indicated sustained decrease in fatigue and pain, and improved QoL in people with CIDP, along with clinical improvement. Two randomized, placebo-controlled Phase-3 studies (MOBILIZE, VITALIZE) are ongoing to confirm these findings."

Clinical • HEOR • P2 data • Fatigue • Pain

Riliprubart Phase 2 Trial Results: Efficacy Analysis Using Immune Neuropathy-No Evidence of Disease Activity Framework (EAN 2026) - No abstract available

Clinical • P2 data

SAFETY OF LONG-TERM RILIPRUBART (SAR445088) TREATMENT IN COLD AGGLUTININ DISEASE: AN OPEN-LABEL STUDY IN RILIPRUBART-NAIVE AND PREVIOUSLY EXPOSED PARTICIPANTS (EHA 2026) - P1 | "Summary/Conclusion In adult participants with CAD, long-term treatment with riliprubart (two dosing regimens in SC or IV) was generally safe and well tolerated, regardless of prior exposure, with few TEAEs reported as related to the study treatment. These findings provide valuable safety and efficacy data supporting the inhibition of complement C1s with riliprubart as a therapeutic approach in CAD."

Clinical • Autoimmune Hemolytic Anemia • Cardiovascular • Complement-mediated Rare Disorders • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hypertension • Immunology • Infectious Disease • Lymphoma • Lymphoplasmacytic Lymphoma • Waldenstrom Macroglobulinemia • C1S

Sanofi…announced that the riliprubart MOBILIZE phase 3 study (clinical study identifier: NCT06290128) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care treatment will be stopped (Sanofi Press Release) - "This decision follows an interim analysis by an independent data monitoring committee, which determined that the MOBILIZE study is unlikely to provide sufficient efficacy. No safety signals related to riliprubart were identified as part of this interim analysis....Sanofi will work closely with investigators and site teams to ensure a wind-down of the MOBILIZE study, with appropriate transition of care for all enrolled patients. Sanofi will conduct a thorough analysis of the MOBILIZE data to inform future research directions and contribute to the broader scientific understanding of CIDP."

DSMB • Trial termination • CNS Disorders • Rare Diseases

Optimizing rare neurological disease trials: Bayesian frameworks and hierarchical models for improved efficiency in clinical trial design. (PubMed, J Biopharm Stat) - "Focusing in this report on a potential redesign of the Phase II trial of SAR445088 in chronic inflammatory demyelinating polyneuropathy (CIDP), we compare the performance of the original design to two potential optimization alternatives...We found that the proposed optimizations demonstrate notable power gains. We advocate enhancing the efficiency of neurological disorders research through the implementation of this optimized Bayesian approach."

Journal • CNS Disorders • Oncology • Pain

Efficacy of Riliprubart in CIDP: Phase 2 Subgroup Analyses [Encore Presentation] (JSNE 2026) - No abstract available

Clinical • P2 data

Safety and Efficacy of Riliprubart in CIDP: 76-week Phase 2 Trial Results [Encore Presentation] (JSNE 2026) - No abstract available

Clinical • P2 data

Exploratory Biomarker Analysis in a Phase 2 Trial of Riliprubart for CIDP [Encore Presentation] (JSNE 2026) - No abstract available

Biomarker • P2 data

Riliprubart Phase 3 MOBILIZE and VITALIZE Trials for CIDP are Actively Enrolling Globally [Encore Presentation] (JSNE 2026) - No abstract available

Clinical • P3 data

Safety and Efficacy of Riliprubart, an Activated C1s-complement Inhibitor in CIDP: 76-week Phase Two Trial Results (AAN 2026) - P2 | "Updated full Part-B data up to Week-76 will be presented at meeting. Conclusions Week-76 results suggest riliprubart may provide sustained clinical benefits in a broad spectrum of participants with CIDP, including those who experience failure/inadequate response/residual disability despite SoC therapy, supporting its development in Phase-3, and a potentially new treatment option."

Clinical • NEFL • Plasma NfL

Riliprubart Phase Three MOBILIZE and VITALIZE Trials for CIDP are Actively Enrolling Globally (AAN 2026) - P2, P3 | "Conclusions MOBILIZE and VITALIZE are evaluating efficacy and safety of riliprubart in CIDP. These Phase-3 trials represent innovations in the field by focusing on key unmet-needs (refractory disease/residual disability) and incorporating an active comparator (IVIg)."

Clinical

LTS: Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP (clinicaltrials.gov) - P3 | N=300 | Enrolling by invitation | Sponsor: Sanofi | Recruiting ➔ Enrolling by invitation

Enrollment status • Pain

Classical Complement Inhibition By SAR445088 (BIVV020) in Adults with Cold Agglutinin Disease: Safety, Tolerability and Activity Results from the Open-Label, Non-Randomized, Single-Dose Phase 1b Study (ASH 2023) - "The classical complement inhibitor sutimlimab, is the first approved pharmacotherapy for treating patients with CAD. SAR445088 was generally well tolerated; no safety concerns were identified in patients with CAD. A single IV dose of SAR445088 led to classical complement inhibition, control of hemolysis, and improvement in anemia, which was sustained for 15 weeks."

Clinical • P1 data • Anemia • Autoimmune Hemolytic Anemia • Cardiovascular • Complement-mediated Rare Disorders • Hematological Disorders • Immunology • Infectious Disease • Meningococcal Infections

LTS17261: Long-term safety and efficacy study of riliprubart in participants with CIDP (ChiCTR) - P3 | N=300 | Recruiting | Sponsor: Huashan Hospital, Fudan University; Huashan Hospital, Fudan University

New P3 trial • Pain

Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P2 | N=98 | Completed | Sponsor: Bioverativ, a Sanofi company | Active, not recruiting ➔ Completed

Trial completion • Pain

VITALIZE: A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Sanofi | Trial completion date: Nov 2027 ➔ Jan 2029 | Trial primary completion date: Nov 2025 ➔ Jul 2027

Trial completion date • Trial primary completion date • Pain

MOBILIZE: A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Sanofi | Trial completion date: Oct 2027 ➔ Nov 2028 | Trial primary completion date: Feb 2026 ➔ May 2027

Trial completion date • Trial primary completion date • Pain

A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Bioverativ, a Sanofi company | Phase classification: P1b ➔ P1

Phase classification • Anemia • Autoimmune Hemolytic Anemia • Complement-mediated Rare Disorders • Hematological Disorders • Immunology

Beneath the surface in autoimmune hemolytic anemia: pathogenetic networks, therapeutic advancements and open questions. (PubMed, Front Immunol) - "Glucocorticoids remain the standard first-line therapy for warm AIHA; in contrast, CAD/CAS is increasingly managed with agents targeting B-cell function or complement activation, including rituximab and sutimlimab...Emerging therapeutics targeting the classical complement pathway include novel anti-C1s monoclonal antibodies such as riliprubart, which exhibits an extended half-life due to enhanced affinity for the neonatal Fc receptor. Parallel strategies aim to disrupt B-cell receptor (BCR) signaling cascades, employing Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, spleen tyrosine kinase (SYK) inhibitors such as fostamatinib and sovleplenib, and phosphoinositide 3-kinase (PI3K) inhibitors such as parsaclisib. Collectively, these advances are reshaping the therapeutic landscape of AIHA toward a precision medicine model guided by mechanistic insights into disease biology. In this review, we delineate the evolving immunopathogenesis of AIHAs and examine..."

Journal • Review • Anemia • Autoimmune Hemolytic Anemia • Complement-mediated Rare Disorders • Hematological Disorders • Immunology • SYK

VITALIZE: A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2027 ➔ Nov 2027

Trial completion date • Pain