PF-06835375 / Pfizer - LARVOL DELTA

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=61 | Recruiting | Sponsor: Pfizer | Trial completion date: Oct 2026 ➔ Oct 2027 | Trial primary completion date: Oct 2026 ➔ Oct 2027

Trial completion date • Trial primary completion date • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=61 | Recruiting | Sponsor: Pfizer | Trial completion date: May 2027 ➔ Oct 2026 | Trial primary completion date: May 2027 ➔ Oct 2026

Trial completion date • Trial primary completion date • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis. (PubMed, Arthritis Res Ther) - P1 | "These data support further development of PF-06835375 to assess the clinical potential for B and Tfh cell depletion as a treatment for autoimmune diseases."

Clinical • Journal • P1 data • PK/PD data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Meningococcal Infections • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • Tetanus • CXCR5

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=61 | Recruiting | Sponsor: Pfizer | Trial completion date: Mar 2025 ➔ May 2027 | Trial primary completion date: Mar 2025 ➔ May 2027

Trial completion date • Trial primary completion date • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

A PHASE 1, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN PATIENTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS (EULAR 2023) - "ADA data did not suggest any clinically relevant impact on PK, PD or safety. Conclusion PF-06835375 was generally well tolerated in patients with seropositive SLE and RA with potent and prolonged B- and cTfh-cell depletion, supporting further development as a treatment for autoimmune diseases."

Clinical • P1 data • PK/PD data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Nephrology • Pain • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • CXCL13 • CXCR5

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=61 | Recruiting | Sponsor: Pfizer | Suspended ➔ Recruiting

Enrollment open • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=61 | Suspended | Sponsor: Pfizer | Trial completion date: Oct 2023 ➔ Mar 2025 | Trial primary completion date: Oct 2023 ➔ Mar 2025

Trial completion date • Trial primary completion date • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=61 | Suspended | Sponsor: Pfizer | N=40 ➔ 61 | Recruiting ➔ Suspended

Enrollment change • Trial suspension • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=75 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=74 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=112 ➔ 74

Enrollment change • Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Pfizer

Clinical • New P2 trial • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=112; Recruiting; Sponsor: Pfizer; Trial completion date: Apr 2021 ➔ Jan 2022; Trial primary completion date: Apr 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=112; Recruiting; Sponsor: Pfizer; Trial completion date: Apr 2022 ➔ Apr 2021; Trial primary completion date: Apr 2022 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=112; Recruiting; Sponsor: Pfizer; Trial completion date: Feb 2022 ➔ Sep 2022; Trial primary completion date: Feb 2022 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date