Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

Pfizer

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: PF-06835375

Study type: Interventional

Funder types: Industry

Identifiers

NCT03334851

C1131001

2017-003077-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR criteria with symptom duration at least 6 months and positive with Rheumatoid Factor and/or anti citrullinated peptide antibody
• Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC Classification Criteria with symptom duration at least 6 months and at least one of the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith antibodies

Exclusion criteria

• Active central nervous system manifestations, systemic vasculitis or pleuro/pericarditis
• Active lupus nephritis
• Treatment with B cell depleting agents within 52 weeks prior to screening

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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74 participants in 14 patient groups

Part A, Cohort 1

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration

Treatment:

Drug: PF-06835375

Drug: Placebo

Part A, Cohort 2

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part A, Cohort 3

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part A, Cohort 4

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part A, Cohort 5

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part A, Cohort 6

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part A, Cohort 7

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part A, Cohort 8

Experimental group

Description:

Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part B, Cohort 1

Experimental group

Description:

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part B, Cohort 2

Experimental group

Description:

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part B, Cohort 3

Experimental group

Description:

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part B, Cohort 4

Experimental group

Description:

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part B, Cohort 5

Experimental group

Description:

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo

Part B, cohort 6

Experimental group

Description:

Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.

Treatment:

Drug: PF-06835375

Drug: Placebo