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Pf-06835375

A groundbreaking clinical trial is underway to assess the potential of PF-06835375, a new drug being studied for the treatment of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). This Phase 1 study aims to evaluate the safety, tolerability, and effectiveness of PF-06835375 in patients with these autoimmune conditions. The trial involves both single and multiple dose administrations, providing valuable insights into how this medication may benefit those suffering from SLE or RA.

Table of Contents

What is PF-06835375?

PF-06835375 is an investigational drug being developed by Pfizer for the treatment of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA)[1]. It is currently undergoing clinical trials to evaluate its safety, tolerability, and effectiveness in patients with these autoimmune conditions.

Target Conditions

The drug is being studied for two main conditions:

  • Systemic Lupus Erythematosus (SLE): This is a chronic autoimmune disease that can affect various parts of the body, including skin, joints, kidneys, brain, and other organs. In SLE, the immune system mistakenly attacks healthy tissues, causing inflammation and damage[1].
  • Rheumatoid Arthritis (RA): This is another chronic autoimmune disorder that primarily affects the joints, causing pain, swelling, and stiffness. Over time, RA can lead to joint deformity and loss of function[1].

Clinical Trial Overview

The clinical trial for PF-06835375 is a Phase 1 study, which is typically the first stage of testing a new drug in humans. The main goals of this trial are to evaluate the drug’s safety, tolerability, pharmacokinetics (how the body processes the drug), and pharmacodynamics (how the drug affects the body)[1].

Key features of the trial include:

  • It is a randomized, multi-center, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either PF-06835375 or a placebo, and neither the participants nor the researchers know who is receiving which treatment[1].
  • The study is divided into two parts: Part A (single ascending dose) and Part B (multiple ascending dose)[1].
  • Approximately 112 participants with seropositive SLE or RA are expected to be enrolled across about 10 study sites[1].

Administration and Dosing

PF-06835375 is administered in two ways, depending on the part of the study:

  • In Part A (single dose), participants receive a single dose of PF-06835375 or placebo via intravenous (IV) administration. This means the drug is given directly into a vein[1].
  • In Part B (multiple doses), participants receive two doses of PF-06835375 or placebo, either via subcutaneous (SC) injection (under the skin) or intravenous administration. These doses are given on Day 1 and Day 29[1].

The doses are ascending, which means they start low and increase gradually based on the results from previous doses. This approach helps researchers determine the safest and most effective dose[1].

Safety and Tolerability

A primary focus of this trial is to assess the safety and tolerability of PF-06835375. Researchers are monitoring several aspects:

  • Dose-Limiting Toxicity (DLT): This refers to side effects that are severe enough to prevent increasing the dose further[1].
  • Treatment-Emergent Adverse Events (TEAEs): These are any unfavorable medical occurrences that happen after starting the treatment[1].
  • Laboratory Abnormalities: Changes in blood tests, including hematology (blood cells), chemistry (various substances in the blood), and urinalysis (urine tests)[1].
  • Vital Signs and ECG Changes: Monitoring of heart rate, blood pressure, and heart rhythm[1].
  • Infections and Infestations: As the drug affects the immune system, researchers are closely monitoring for any increased risk of infections[1].

Pharmacokinetics

Pharmacokinetics refers to how the body processes the drug. The study is measuring several parameters:

  • Maximum Concentration (Cmax): The highest level of the drug in the blood[1].
  • Time to Maximum Concentration (Tmax): How long it takes to reach the highest drug level[1].
  • Area Under the Curve (AUC): A measure of the total exposure to the drug over time[1].
  • Minimum Concentration (Cmin): The lowest level of the drug in the blood between doses[1].

These measurements help researchers understand how the drug moves through the body and how long it remains active[1].

Pharmacodynamics

Pharmacodynamics looks at how the drug affects the body. For PF-06835375, researchers are particularly interested in its effects on certain types of immune cells:

  • B Cell Depletion: The study is measuring the maximum decrease in B cells, which are a type of white blood cell involved in producing antibodies[1].
  • Circulating Follicular T Helper-like (cTfh) Cell Depletion: These are another type of immune cell that helps B cells produce antibodies[1].

By monitoring these cells, researchers can understand how PF-06835375 is affecting the immune system and potentially reducing autoimmune activity[1].

Immunogenicity

Immunogenicity refers to the ability of a substance to provoke an immune response. In this study, researchers are checking for:

  • Anti-Drug Antibodies (ADA): These are antibodies that the body might produce against PF-06835375 itself[1].
  • Neutralizing Antibodies (NAb): These are a specific type of ADA that could potentially reduce the effectiveness of the drug[1].

Monitoring for these antibodies helps researchers understand how the body responds to PF-06835375 over time and whether this response might affect the drug’s efficacy or safety[1].

Aspect Details
Study Type Phase 1, randomized, multi-center, double-blind, placebo-controlled
Drug PF-06835375
Conditions Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA)
Study Design Part A: Single ascending dose, Part B: Multiple ascending dose
Administration Intravenous (IV) or subcutaneous (SC)
Primary Outcomes Safety, tolerability, adverse events, laboratory abnormalities
Secondary Outcomes B cell and cTfh cell depletion, pharmacokinetics, immunogenicity
Duration Up to 225 days (Part A), up to 281 days (Part B)

FAQ

  • What is PF-06835375? PF-06835375 is an investigational drug being studied for the treatment of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). It is administered either intravenously or subcutaneously in this clinical trial.
  • What is the purpose of this clinical trial? The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (how the drug affects the body) of PF-06835375 in patients with seropositive SLE or RA.
  • How is the trial structured? The trial is divided into two parts: Part A involves single ascending dose cohorts, while Part B consists of multiple ascending dose cohorts. It is a randomized, double-blind, placebo-controlled study conducted at multiple centers.
  • What are the main outcomes being measured in this trial? The main outcomes include the number of participants experiencing dose-limiting toxicity, treatment-emergent adverse events, changes in laboratory values, vital signs, and electrocardiogram readings. The study also measures the effects of the drug on B cells and circulating follicular T helper-like cells.
  • How long does the trial last for participants? The duration varies, but participants may be involved for up to 225 days in Part A and up to 281 days in Part B. This includes the treatment period and follow-up assessments.

Ongoing Clinical Trials on Pf-06835375

  • Study on the Safety and Efficacy of PF-06835375 and Diphenhydramine Hydrochloride for Adults with Moderate to Severe Primary Immune Thrombocytopenia

    Not recruiting

    1 1 1
    Investigated drugs:
    Czechia Hungary Poland

Glossary

  • Systemic Lupus Erythematosus (SLE): A chronic autoimmune disease that can affect various parts of the body, including skin, joints, kidneys, brain, and other organs.
  • Rheumatoid Arthritis (RA): A chronic inflammatory disorder that primarily affects joints, causing pain, swelling, and potential joint deformity.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics: The study of how a drug affects the body, including its mechanism of action and relationship between drug concentration and effect.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a decrease in dose.
  • Treatment-Emergent Adverse Event (TEAE): Any unfavorable medical occurrence that appears or worsens after starting the study treatment.
  • B cells: A type of white blood cell that plays a crucial role in the immune system, particularly in producing antibodies.
  • Circulating Follicular T Helper-like (cTfh) cells: A subset of T cells that help B cells produce antibodies and are found in the bloodstream.
  • Intravenous (IV) administration: Delivery of a medication directly into a vein using a needle or tube.
  • Subcutaneous (SC) administration: Injection of a medication into the layer of tissue between the skin and muscle.

References

  1. https://clinicaltrials.gov/study/NCT03334851