Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03334851 |
Recruitment Status :
Completed
First Posted : November 7, 2017
Last Update Posted : April 7, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus Rheumatoid Arthritis | Drug: PF-06835375 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | 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 |
Actual Study Start Date : | November 17, 2017 |
Actual Primary Completion Date : | February 15, 2022 |
Actual Study Completion Date : | February 15, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Part A, Cohort 1
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration
|
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 2
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
|
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 3
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
|
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 4
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
|
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 5
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
|
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 6
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
|
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 7
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
|
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 8
Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.
|
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 B, Cohort 1
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.
|
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 B, Cohort 2
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
|
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 B, Cohort 3
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
|
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 B, Cohort 4
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
|
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 B, Cohort 5
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
|
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 B, cohort 6
Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.
|
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. |
- Number of participants with adverse events (AEs) by seriousness and relationship to treatment [ Time Frame: Day 1 through approximately Day 112 ]
- Number of participants with change from baseline in labboratory test results [ Time Frame: Day 1 through approximately Day 112 ]
- Number of participants with clinically relevant changes from baseline in ECG parameters [ Time Frame: Day 1 through approximately Day 112 ]
- Number of participants with infections [ Time Frame: Day 1 through approximately Day 112 ]
- Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 through approximately Day 112 ]
- Number of participants with dose limiting adverse events [ Time Frame: Day 1 through approximately Day 112 ]
- Change from baseline in the number of specific B cells (subset) over time following single and multiple doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Change from baseline in the number of specific T cells (subset) over time following single and multiple doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Number of participants with anti-drug antibodies (ADA) to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Maximum Observed Plasma Concentration (Cmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Number of participants with neutralizing antibodies to PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Apparent Clearance (CL) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Plasma Decay Half-Life of PF-06835375 [ Time Frame: Day 1 to approximately Day 112 ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Volume of Distribution at Steady State (Vss) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- AUCtau of PF-06835375 (dose normalized) [ Time Frame: Day 1 through approximately Day 112 ]
- Average Concentration (Cav) of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Mean residence of time for PF-06835375 [ Time Frame: Day 1 though approximately Day 112 ]
- Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]
- Bioavailability of PF-06835375 subcutaneous doses compared to intravenous doses of PF-06835375 [ Time Frame: Day 1 through approximately Day 112 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334851

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT03334851 |
Other Study ID Numbers: |
C1131001 2017-003077-34 ( EudraCT Number ) |
First Posted: | November 7, 2017 Key Record Dates |
Last Update Posted: | April 7, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
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/data_requests. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Arthritis Arthritis, Rheumatoid Lupus Erythematosus, Systemic Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |