An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

NCT07029555 | Recruiting Phase 1

• 1 other identifier: CPIT565C12101
• Study Type: interventional
• Target: 57
• Locations: 9 countries
• Sites: 14

Brief Summary

The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).

Conditions

Rheumatoid Arthritis

Keywords

PIT565; ascending dose; rheumatoid arthritis; B cells

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.

  6 months

Secondary Outcomes (3)

• Pharmacokinetic parameters of PIT565: Maximum serum Concentration [Cmax]

  up to 6 months

• Pharmacokinetic parameters of PIT565: Area under serum concentration (AUC)

  up to 6 months

• Concentrations of anti-PIT565 antibodies

  Baseline, up to 6 months

Study Arms (8)

PIT565 dose 1

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

PIT565 dose 2

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

PIT565 dose 3

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

PIT565 dose 4

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

PIT565 dose 5

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

PIT565 dose 6

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

PIT565 dose 7

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

PIT565 dose 8

EXPERIMENTAL

Study treatment will be provided in vials as open-label participant specific supply.

Biological: PIT565

Interventions

PIT565 BIOLOGICAL

Study treatment will be provided in vials as open-label participant specific supply.

PIT565 dose 1; PIT565 dose 2; PIT565 dose 3; PIT565 dose 4; PIT565 dose 5; PIT565 dose 6; PIT565 dose 7; PIT565 dose 8

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study. Male and female patients, aged 18 to 75 years at screening, diagnosed with RA according to the 2010 ACR/EULAR or 1987 ACR classification at least 12 weeks prior to screening.
• Immunization (primary or from vaccinations) against pneumococcus, influenza, meningococcus and COVID-19 infection at least 2 weeks prior to the first dosing. Local guidelines should be followed to determine requirement for vaccination (or booster), as well as the type and schedule of vaccination.

You may not qualify if:

• Any of the following cardiac conditions
• Unstable angina, myocardial infarction, coronary artery bypass graft (CABG), or stroke within 6 months prior to screening
• Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2) or uncontrolled hypertension
• Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree atrioventricular block without a pacemaker
• History of familial long QT syndrome or known family history of Torsades-de- Pointes
• Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) at screening
• Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (14)

Novartis Investigative Site

CABA, C1181ACH, Argentina

RECRUITING

Novartis Investigative Site

Sofia, 1618, Bulgaria

RECRUITING

Novartis Investigative Site

Beijing, 100191, China

RECRUITING

Novartis Investigative Site

Beijing, 100730, China

RECRUITING

Novartis Investigative Site

Brest, 29200, France

RECRUITING

Novartis Investigative Site

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Novartis Investigative Site

Jena, Thuringia, 07740, Germany

RECRUITING

Novartis Investigative Site

Mainz, 55131, Germany

RECRUITING

Novartis Investigative Site

Szeged, 6725, Hungary

RECRUITING

Novartis Investigative Site

Leiden, South Holland, 2333 CL, Netherlands

RECRUITING

Novartis Investigative Site

Cluj-Napoca, Cluj, 400006, Romania

RECRUITING

Novartis Investigative Site

Bucharest, 011658, Romania

RECRUITING

Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 16, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); NL (1); FR (2); HU (1); AR (1); RO (2); CN (2); BU (1); DE (2)