An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

Phase 1

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: PIT565

• Registration Number: NCT07029555
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

This is an open-label, uncontrolled study in participants with RA. PIT565 will be administered subcutaneously. The objective of the study is to assess the safety and efficacy of PIT565 in participants with RA.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Study Start: 2025-06-12
• Study First Posted: 2025-06-19
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-30
• Primary Completion: 2028-05-15
• Study Completion: 2028-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• 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, 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.

Exclusion Criteria

• Any of the following cardiac conditions

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

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PIT565 dose 1	PIT565	Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 2	PIT565	Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 3	PIT565	Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 4	PIT565	Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 5	PIT565	Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 6	PIT565	Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 7	PIT565	Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 8	PIT565	Study treatment will be provided in vials as open-label participant specific supply.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of PIT565: Maximum serum Concentration [Cmax]	up to 6 months	Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Pharmacokinetic parameters of PIT565: Area under serum concentration (AUC)	up to 6 months	AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).
Concentrations of anti-PIT565 antibodies	Baseline, up to 6 months	To assess the immunogenicity (IG) of PIT565

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Beijing, China