Systemic Lupus Erythematosus, SLEPhase 1NCT06335979
An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
A Phase 1 study testing PIT565 in people with Systemic Lupus Erythematosus, SLE, run by Novartis Pharmaceuticals at 11 sites in 6 countries.
Trial summary
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus, SLE
- What is being tested?
- PIT565
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 8 Oct 2024to 17 Nov 2027
- 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
- Diagnosis of SLE according to the 2019 ACR/EULAR criteria
- Documentation of SLE autoantibodies
- Active SLE disease, as demonstrated by a SLEDAI-2K ≥ 4 at screening
- Failure to respond to standard-of-care medicines for the treatment of SLE as detailed in the protocol
- Immunization against pneumococcus, meningococcus, influenza, and COVID-19
Who cannot join
- Severe SLE-related organ damage dysfunction or life-threatening disease at screening.
- Any acute, severe lupus-related flare during screening that needs immediate treatment such as acute CNS lupus (e.g., psychosis, epilepsy) or catastrophic antiphospholipid syndrome.
- Presence of severe lupus kidney disease as defined by worsening proteinuria or estimated glomerular filtration rate (eGFR) which in the opinion of the Investigator requires immunosuppressive induction or maintenance treatment at screening.
- History or current diagnosis of ECG or cardiac abnormalities indicating a significant risk of safety for participants.
- Use of prohibited medication defined in the protocol.
- Clinically significant active, opportunistic, chronic or recurrent infection (including, HIV, HBV, HCV) confirmed one month prior to or during screening.
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- Serious medical illness likely to interfere with participation in this clinical study.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Spain3 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
China2 sites
Novartis Investigative Site
Beijing, 100191
Novartis Investigative Site
Beijing, 100730
Germany2 sites
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Mainz, 55131
Hungary2 sites
Novartis Investigative Site
Budapest, H-1083
Novartis Investigative Site
Szeged, 6725
Netherlands1 site
Novartis Investigative Site
Leiden, South Holland, 2333 CL
About this study
Official title: A Phase Ib, Open-label, Ascending Dose Study With Step-up Doses to Assess Safety, Tolerability, and Pharmacokinetics of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
Read the detailed description
This is an open-label, ascending dose, uncontrolled study in participants with SLE systemic lupus erythematosus (SLE). PIT565 will be administered subcutaneously (s.c.) following premedication.
Up to 8 cohorts are planned. Every cohort will start with 3 sentinel participants and, depending on safety as well as observed biological activity, may have additional optional participants. The decision to escalate the dose from one cohort to the next will be based both on safety and PD data. After the identification of a dose level that has been declared safe and has induced predefined B cell depletion in 100% of the participants (candidate dose level), the cohort from this candidate dose level can be expanded with up to 12 additional participants (up to a total of 15 participants per cohort).
- Conditions
- Systemic Lupus Erythematosus, SLE
- Being tested
- PIT565
- Keywords
- Systemic lupus erythematosus, SLE, ascending dose, B cells
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIT565Drug
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Dose level 1 Receives: Drug: PIT565 |
| Cohort 2 | Experimental | Dose level 2 Receives: Drug: PIT565 |
| Cohort 3 | Experimental | Dose level 3 Receives: Drug: PIT565 |
| Cohort 4 | Experimental | Dose level 4 Receives: Drug: PIT565 |
| Cohort 5 | Experimental | Dose level 5 Receives: Drug: PIT565 |
| Cohort 6 | Experimental | Dose level 6 Receives: Drug: PIT565 |
| Cohort 7 | Experimental | Dose level 7 Receives: Drug: PIT565 |
| Cohort 8 | Experimental | Dose level 8 Receives: Drug: PIT565 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Safety assessments of PIT565 including changes in vital signs, electrocardiograms (ECG) and laboratory results from baseline
Measured: From Study Day 1 until Study Day 180
Secondary outcomes (2)
Maximum Observed Blood Concentrations (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: From pre-dose Day 1 until Day 29
Presence/absence of Anti-drug Antibodies
Assess immunogenicity of PIT565 at pre-dose, and over time
Measured: From pre-dose Day 1 until Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start8 Oct 2024
- Primary completion17 Nov 2027 (estimated)
- Study completion17 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus, SLEStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335979
- Sponsor's protocol ID
- CPIT565B12101
- Other IDs
- 2023-510025-14-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 With Step-up Doses to Assess Safety, Tolerability, and Pharmacokinetics of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
- ClinicalTrials.gov ID
- NCT06335979
- Acronym / sponsor ID
- CPIT565B12101
- Conditions
- Systemic Lupus Erythematosus, SLE
- Keywords
- Systemic lupus erythematosus, SLE, ascending dose, B cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 17 Nov 2027 (estimated)
- Study completion
- 17 Nov 2027 (estimated)
- First posted
- 28 Mar 2024 (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 SLE
Detailed description
This is an open-label, ascending dose, uncontrolled study in participants with SLE systemic lupus erythematosus (SLE). PIT565 will be administered subcutaneously (s.c.) following premedication.
Up to 8 cohorts are planned. Every cohort will start with 3 sentinel participants and, depending on safety as well as observed biological activity, may have additional optional participants. The decision to escalate the dose from one cohort to the next will be based both on safety and PD data. After the identification of a dose level that has been declared safe and has induced predefined B cell depletion in 100% of the participants (candidate dose level), the cohort from this candidate dose level can be expanded with up to 12 additional participants (up to a total of 15 participants per cohort).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PIT565Dose level 1 |
| Cohort 2 | Experimental | Drug: PIT565Dose level 2 |
| Cohort 3 | Experimental | Drug: PIT565Dose level 3 |
| Cohort 4 | Experimental | Drug: PIT565Dose level 4 |
| Cohort 5 | Experimental | Drug: PIT565Dose level 5 |
| Cohort 6 | Experimental | Drug: PIT565Dose level 6 |
| Cohort 7 | Experimental | Drug: PIT565Dose level 7 |
| Cohort 8 | Experimental | Drug: PIT565Dose level 8 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of SLE according to the 2019 ACR/EULAR criteria
- Documentation of SLE autoantibodies
- Active SLE disease, as demonstrated by a SLEDAI-2K ≥ 4 at screening
- Failure to respond to standard-of-care medicines for the treatment of SLE as detailed in the protocol
- Immunization against pneumococcus, meningococcus, influenza, and COVID-19
Key exclusion criteria (9 listed)
- Severe SLE-related organ damage dysfunction or life-threatening disease at screening.
- Any acute, severe lupus-related flare during screening that needs immediate treatment such as acute CNS lupus (e.g., psychosis, epilepsy) or catastrophic antiphospholipid syndrome.
- Presence of severe lupus kidney disease as defined by worsening proteinuria or estimated glomerular filtration rate (eGFR) which in the opinion of the Investigator requires immunosuppressive induction or maintenance treatment at screening.
- History or current diagnosis of ECG or cardiac abnormalities indicating a significant risk of safety for participants.
- Use of prohibited medication defined in the protocol.
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 |
|---|---|---|
| PIT565In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time frame: From Study Day 1 until Study Day 180
Safety assessments of PIT565 including changes in vital signs, electrocardiograms (ECG) and laboratory results from baseline
2 secondary outcomes
Maximum Observed Blood Concentrations (Cmax)
Time frame: From pre-dose Day 1 until Day 29
Presence/absence of Anti-drug Antibodies
Time frame: From pre-dose Day 1 until Day 180
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
11 sites in 6 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 Systemic Lupus Erythematosus, SLE, run by Novartis Pharmaceuticals at 11 sites in 6 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 5 inclusion and 9 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 11 sites in Spain, China, Germany, Hungary, Netherlands and 1 more country. 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?
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) (time frame: From Study Day 1 until Study Day 180). 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.