C1131003 - AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA - C1131003

Start Date02 Feb 2022

Sponsor / Collaborator

Pfizer Inc.

NCT05070845 / RecruitingPhase 2

AN INTERVENTIONAL PHASE 2, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA

This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (>3 months and ≤12 months), or chronic (>12 months) ITP

Start Date02 Feb 2022

Sponsor / Collaborator

Pfizer Inc.

NCT03334851 / CompletedPhase 1

A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS

This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites.

Start Date17 Nov 2017

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with PF-06835375

100 Translational Medicine associated with PF-06835375

100 Patents (Medical) associated with PF-06835375

Literatures (Medical) associated with PF-06835375

Arthritis Research & Therapy

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

Article

Author: Beebe, Jean S ; Sloan, Abigail ; Koride, Sarita ; Saxena, Madhurima ; Peeva, Elena ; Chindalore, Vishala ; Lubaczewski, Shannon ; Vincent, Michael S ; Cohen, Stanley ; Martin, David A ; Hassan-Zahraee, Mina ; Xi, Li ; Guan, Shunjie ; Chu, Myron ; Stevens, Erin ; Salganik, Mikhail ; Levin, Robert ; Hyde, Craig

AbstractBackgroundThe objective of this study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF‑06835375, a potent selective afucosyl immunoglobulin G1 antibody targeting C-X-C chemokine receptor type 5 (CXCR5) that potentially depletes B cells, follicular T helper (Tfh) cells, and circulating Tfh-like (cTfh) cells, in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).MethodsThis first-in-human, multicenter, double-blind, sponsor-open, placebo-controlled Phase 1 study recruited patients aged 18–70 years with SLE or RA. In Part A, patients received single doses of intravenous PF-06835375 (dose range: 0.03–6 mg) or placebo in six sequential single ascending dose (SAD) cohorts. In Part B, patients received repeat doses of subcutaneous PF-06835375 (dose range: 0.3–10 mg) or placebo on Days 1 and 29 in five multiple ascending dose (MAD) cohorts. Tetanus/Diphtheria (Td) and Meningococcal B (MenB/Trumenba™) vaccines were administered at Day 4 (Td and MenB) and Week 8 (MenB only) to assess PF-06835375 functional effects. Endpoints included treatment-emergent adverse events (TEAEs), pharmacokinetic parameters, pharmacodynamic effects on B and cTfh cells, and biomarker counts, vaccine response, and exploratory differential gene expression analysis. Safety, pharmacokinetic, and pharmacodynamic endpoints are summarized descriptively. The change from baseline of B and Tfh cell-specific genes over time was calculated using a prespecified mixed-effects model, with a false discovery rate < 0.05 considered statistically significant.ResultsIn total, 73 patients were treated (SAD cohorts: SLE, n = 17; RA, n = 14; MAD cohorts: SLE, n = 22; RA, n = 20). Mean age was 53.3 years. Sixty-two (84.9%) patients experienced TEAEs (placebo n = 17; PF-06835375 n = 45); most were mild or moderate. Three (9.7%) patients experienced serious adverse events. Mean t1/2 ranged from 3.4–121.4 h (SAD cohorts) and 162.0–234.0 h (MAD cohorts, Day 29). B and cTfh cell counts generally showed dose-dependent reductions across cohorts (range of mean maximum depletion: 67.3–99.3%/62.4–98.7% [SAD] and 91.1–99.6%/89.5–98.1% [MAD], respectively). B cell-related genes and pathways were significantly downregulated in patients treated with PF-06835375.ConclusionsThese data support further development of PF-06835375 to assess the clinical potential for B and Tfh cell depletion as a treatment for autoimmune diseases.Trial registrationClinicalTrials.gov identifier: NCT03334851.

100 Deals associated with PF-06835375

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Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	Phase 2	CZ	Pfizer Inc.	02 Feb 2022
Purpura, Thrombocytopenic, Idiopathic	Phase 2	AU	Pfizer Inc.	02 Feb 2022
Purpura, Thrombocytopenic, Idiopathic	Phase 2	CA	Pfizer Inc.	02 Feb 2022
Purpura, Thrombocytopenic, Idiopathic	Phase 2	GB	Pfizer Inc.	02 Feb 2022
Purpura, Thrombocytopenic, Idiopathic	Phase 2	HU	Pfizer Inc.	02 Feb 2022
Purpura, Thrombocytopenic, Idiopathic	Phase 2	US	Pfizer Inc.	02 Feb 2022
Purpura, Thrombocytopenic, Idiopathic	Phase 2	PL	Pfizer Inc.	02 Feb 2022
Lupus Vulgaris	Phase 1	-	Pfizer Inc.	-
Rheumatoid Arthritis	Preclinical	US	Pfizer Inc.	17 Nov 2017
Systemic Lupus Erythematosus	Preclinical	US	Pfizer Inc.	17 Nov 2017

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