Rheumatoid ArthritisPhase 1NCT07029555
An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis
A Phase 1 study testing PIT565 in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 16 sites in 9 countries.
Trial summary
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- PIT565
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 16 sitesin 9 countries
- Study dates
- 12 Jun 2025to 16 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
16 sites in 9 countries.
16 sites in 9 countries
France3 sites
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Le Kremlin-Bicêtre, 94275
Novartis Investigative Site
Paris, 75014
Argentina2 sites
Novartis Investigative Site
CABA, C1181ACH
Novartis Investigative Site
Pilar, Buenos Aires, B1629AHJ
China2 sites
Novartis Investigative Site
Beijing, 100191
Novartis Investigative Site
Beijing, 100730
Germany2 sites
Novartis Investigative Site
Jena, Thuringia, 07740
Novartis Investigative Site
Mainz, 55131
Romania2 sites
Novartis Investigative Site
Bucharest, 011658
Novartis Investigative Site
Cluj-Napoca, Cluj, 400006
Spain2 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Netherlands1 site
Novartis Investigative Site
Leiden, South Holland, 2333 CL
About this study
Official title: A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565, in participants with rheumatoid arthritis (RA).
Read the 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 of PIT565 in participants with RA.
- Conditions
- Rheumatoid Arthritis
- Being tested
- PIT565
- Keywords
- PIT565, ascending dose, rheumatoid arthritis, B cells
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIT565Biological
Study treatment will be provided in vials as open-label participant specific supply.
| Study group | Role | What they receive |
|---|---|---|
| PIT565 dose 1 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
| PIT565 dose 2 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
| PIT565 dose 3 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
| PIT565 dose 4 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
| PIT565 dose 5 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
| PIT565 dose 6 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
| PIT565 dose 7 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
| PIT565 dose 8 | Experimental | Study treatment will be provided in vials as open-label participant specific supply. Receives: Biological: PIT565 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Pharmacokinetic parameters of PIT565: Maximum serum Concentration [Cmax]
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Measured: up to 6 months
Pharmacokinetic parameters of PIT565: Area under serum concentration (AUC)
AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1).
Measured: up to 6 months
Concentrations of anti-PIT565 antibodies
To assess the immunogenicity (IG) of PIT565
Measured: Baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start12 Jun 2025
- Primary completion15 May 2028 (estimated)
- Study completion16 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029555
- Sponsor's protocol ID
- CPIT565C12101
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label, Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of PIT565 in Participants With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT07029555
- Acronym / sponsor ID
- CPIT565C12101
- Conditions
- Rheumatoid Arthritis
- Keywords
- PIT565, ascending dose, rheumatoid arthritis, B cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 16 May 2028 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of PIT565 in participants with RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PIT565 dose 1 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 2 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 3 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 4 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 5 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 6 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 7 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
| PIT565 dose 8 | Experimental | Biological: PIT565Study treatment will be provided in vials as open-label participant specific supply. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIT565Study treatment will be provided in vials as open-label participant specific supply. | Biological | PIT565 dose 1, PIT565 dose 2, PIT565 dose 3, PIT565 dose 4, PIT565 dose 5, PIT565 dose 6, PIT565 dose 7, PIT565 dose 8 |
Primary outcome
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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.
3 secondary outcomes
Pharmacokinetic parameters of PIT565: Maximum serum Concentration [Cmax]
Time frame: up to 6 months
Pharmacokinetic parameters of PIT565: Area under serum concentration (AUC)
Time frame: up to 6 months
Concentrations of anti-PIT565 antibodies
Time frame: Baseline, up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PIT565 in people with Rheumatoid Arthritis, run by Novartis Pharmaceuticals at 16 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Argentina, China, Germany, Romania and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.