PF-08154225
Drugimmune-modulating agent
NCT Number: NCT07782450
The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases. An autoimmune disease is a condition that makes a person's immune system attack its healthy cells by mistake. This study is particularly looking at autoimmune diseases called as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Idiopathic Inflammatory Myositis (IIM) or Systemic Sclerosis (SSc).
This study is divided into 3 parts: Part 1a, Part 1b and Part 2. Parts 1a and 1b are seeking participants with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis and Part 2 with also Idiopathic Inflammatory Myositis (IIM) or Systemic Sclerosis (SSc).
Participants can take part only in one part of the study.
All participants in this study will receive PF-08154225 at the study clinic. In Part 1a participants will receive single administration of PF-08154225 after which they will be observed at the study clinic during regular visits through week 16 or longer.
In Part 1b the participants will receive multiple administration of PF-08154225 after which they will be monitored in similar a manner as in Part 1a through week 24 or longer.
In Part 2 participants will receive multiple administrations of PF-08154225. After the last injection they will be monitored for safety through week 52 or longer.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 1 / Phase 2
This clinical trial consists of Part I and Part II. Phase I consists of dose escalation. The main goal of dose escalation is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-08154225 in participants with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA), and the main goal of Part II is to assess effects of PF-08154225 on the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy in participants with SLE or RA or IIM or SSc.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Select Inclusion Criteria
Select Exclusion Criteria
immune-modulating agent
Time frame: From first dose through End of Study (up to Week 16 in Part 1a, Week 24 in Part 1b and Week 52 in Part2)
An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Time frame: During the DLT observation period (up to 22 days after the last dose)
Time frame: From first dose of study intervention through End of Study (up to Week 16 in Part 1a, Week 24 in Part 1b and Week 52 in Part 2)
Time frame: From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)
Time frame: From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)
Time frame: From first dose through the last pharmacokinetic assessment (up to Week 16 in Part 1a and up to Week 24 in Part 1b)
AUClast, AUCinf, and AUCtau will be assessed as data permit.
Time frame: From first dose of study intervention through End of Study (Week 16 for Part 1a, week 24 for Part 1b and Week 52 for Part 2 or longer if extension of the follow up was needed
Time frame: From first dose of study intervention through End of Study (Week 16 for Part 1a, Week 24 for Part 1b and Week 52 for Part2
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Up to Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Up to Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Up to Week 52
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
A PHASE 1/2, MULTI-CENTER, OPEN-LABEL, SINGLE- AND MULTIPLE-DOSEESCALATION, DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PRELIMINARY EFFICACY OF PF-08154225, IN PARTICIPANTS WITH AUTOIMMUNE DISEASES INCLUDING ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), OR RHEUMATOID ARTHRITIS (RA), OR IDIOPATHIC INFLAMMATORY MYOSITIS (IIM) OR SYSTEMIC SCLEROSIS (SSC)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06970951
Arthritis, Arthritis, Rheumatoid
Suzhou, Jiangsu, China
View Trial DetailsNCT05869955
Arthritis, Arthritis, Rheumatoid
Aurora, Colorado, United States
View Trial DetailsNCT07077304
ANCA Associated Vasculitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Paris, France
View Trial DetailsNCT05879419
Ankylosis, Arthritis
São Paulo, Brazil
View Trial Details