An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).
NCT ID: NCT06335979
Last Updated: 2026-01-02
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
54 participants
INTERVENTIONAL
2024-10-08
2027-07-09
Brief Summary
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Detailed Description
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Up to 8 cohorts are planned. Every cohort will have 3 sentinel participants and, depending on safety as well as observed biological activity, may have up to 3 additional optional participants (up to 6 participants per cohort). 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 optionally be enriched with 6 additional participants (up to a total of 12 participants).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
Dose level 1
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Cohort 2
Dose level 2
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Cohort 3
Dose level 3
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Cohort 4
Dose level 4
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Cohort 5
Dose level 5
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Cohort 6
Dose level 6
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Cohort 7
Dose level 7
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Cohort 8
Dose level 8
PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Interventions
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PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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.
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Sofia, , Bulgaria
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Szeged, , Hungary
Novartis Investigative Site
Leiden, South Holland, Netherlands
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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2023-510025-14-00
Identifier Type: OTHER
Identifier Source: secondary_id
CPIT565B12101
Identifier Type: -
Identifier Source: org_study_id
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