Trying increasing doses of PIT565 for rheumatoid arthritis
A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)
This will try rising subcutaneous doses of PIT565 in adults with rheumatoid arthritis to see if it is safe and how the body handles the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 14 sites (CABA and 13 other locations) |
| Trial ID | NCT07029555 on ClinicalTrials.gov |
What this trial studies
This is an open-label, uncontrolled Phase 1 ascending-dose study that gives PIT565 by subcutaneous injection to adults with rheumatoid arthritis. The primary goals are to characterize safety, tolerability, and pharmacokinetics across dose levels. Participants will be monitored for adverse events, vital signs, and blood levels of the drug over a defined follow-up period. The design enrolls successive cohorts that receive higher doses if earlier doses meet safety criteria.
Who should consider this trial
Good fit: Adults aged 18 to 75 with a confirmed rheumatoid arthritis diagnosis (per 2010 ACR/EULAR or 1987 ACR criteria) who meet vaccination requirements and other site screening criteria are the intended participants.
Not a fit: Patients with recent major cardiac events, unstable or uncontrolled heart disease, significant arrhythmias, or other exclusionary medical conditions are unlikely to be eligible and may not benefit from participation.
Why it matters
Potential benefit: If successful, PIT565 could become a new B-cell–directed treatment option that may help control rheumatoid arthritis symptoms for some patients.
How similar studies have performed: B-cell–targeting therapies have shown benefit in rheumatoid arthritis, but PIT565 itself is investigational and has not yet been demonstrated effective in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
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, 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. 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.
Where this trial is running
CABA and 13 other locations
- Novartis Investigative Site — Caba, Argentina (Recruiting)
- Novartis Investigative Site — Sofia, Bulgaria (Recruiting)
- Novartis Investigative Site — Beijing, China (Recruiting)
- Novartis Investigative Site — Beijing, China (Recruiting)
- Novartis Investigative Site — Brest, France (Recruiting)
- Novartis Investigative Site — Le Kremlin-Bicêtre, France (Recruiting)
- Novartis Investigative Site — Jena, Thuringia, Germany (Recruiting)
- Novartis Investigative Site — Mainz, Germany (Recruiting)
- Novartis Investigative Site — Szeged, Hungary (Recruiting)
- Novartis Investigative Site — Leiden, South Holland, Netherlands (Recruiting)
- Novartis Investigative Site — Cluj-Napoca, Cluj, Romania (Recruiting)
- Novartis Investigative Site — Bucharest, Romania (Recruiting)
- Novartis Investigative Site — Santiago Compostela, A Coruna, Spain (Recruiting)
- Novartis Investigative Site — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.