An Ascending Dose Study of PIT565 in Participants With Systemic Lupus Erythematosus (SLE).

May 27, 2026 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1612
        • Withdrawn
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Beijing, China, 100191
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, H-1083
        • Recruiting
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 CL
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Recruiting
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela, A Coruna, Spain, 15706
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Novartis Investigative Site
      • Sankt Gallen, Switzerland, 9007
        • Withdrawn
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Dose level 1
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Experimental: Cohort 2
Dose level 2
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Experimental: Cohort 3
Dose level 3
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Experimental: Cohort 4
Dose level 4
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Experimental: Cohort 5
Dose level 5
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Experimental: Cohort 6
Dose level 6
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Experimental: Cohort 7
Dose level 7
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.
Experimental: Cohort 8
Dose level 8
Drug: PIT565
In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From Study Day 1 until Study Day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence/absence of Anti-drug Antibodies
Time Frame: From pre-dose Day 1 until Day 180
Assess immunogenicity of PIT565 at pre-dose, and over time
From pre-dose Day 1 until Day 180
Maximum Observed Blood Concentrations (Cmax)
Time Frame: From pre-dose Day 1 until Day 29
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1).
From pre-dose Day 1 until Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Estimated)

November 17, 2027

Study Completion (Estimated)

November 17, 2027

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPIT565B12101
  • 2023-510025-14-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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