An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis
NCT ID: NCT07029555
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
57 participants
INTERVENTIONAL
2025-06-12
2028-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PIT565 dose 1
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 2
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 3
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 4
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 5
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 6
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 7
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
PIT565 dose 8
Study treatment will be provided in vials as open-label participant specific supply.
PIT565
Study treatment will be provided in vials as open-label participant specific supply.
Interventions
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PIT565
Study treatment will be provided in vials as open-label participant specific supply.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
CABA, , Argentina
Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Jena, Thuringia, Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Leiden, South Holland, Netherlands
Novartis Investigative Site
Cluj-Napoca, Cluj, Romania
Novartis Investigative Site
Bucharest, , Romania
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CPIT565C12101
Identifier Type: -
Identifier Source: org_study_id
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