| Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
|
| 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.
|
| Not Provided
|
| Interventional
|
| Phase 1
|
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
|
- Drug: PF-06835375
Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
- Drug: Placebo
Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
|
- Experimental: Part A, Cohort 1
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 2
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 3
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 4
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 5
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 6
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 7
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part A, Cohort 8
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 1
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 2
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 3
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 4
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, Cohort 5
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
- Experimental: Part B, cohort 6
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
Interventions:
- Drug: PF-06835375
- Drug: Placebo
|
| Not Provided
|
| |
| Recruiting
|
| 112
|
|
Same as current
|
| June 3, 2022
|
| June 3, 2022 (Final data collection date for primary outcome measure)
|
|
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
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 70 Years (Adult, Older Adult)
|
| No
|
|
| Puerto Rico, United States
|
|
|
| |
| NCT03334851
|
C1131001
2017-003077-34 ( EudraCT Number )
|
| No
|
| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
|
| Plan to Share IPD: |
No |
| Plan Description: |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da.... |
|
| Pfizer
|
| Pfizer
|
| Not Provided
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer
|
| February 2020
|
