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

NCT06335979 | Recruiting Phase 1

• 2 other identifiers: CPIT565B121012023-510025-14-00
• Study Type: interventional
• Target: 54
• Locations: 7 countries
• Sites: 13

Brief Summary

The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE

Conditions

Systemic Lupus Erythematosus, SLE

Keywords

Systemic lupus erythematosus; SLE; ascending dose; B cells

Outcome Measures

Primary Outcomes (1)

• 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

  From Study Day 1 until Study Day 180

Secondary Outcomes (2)

• Maximum Observed Blood Concentrations (Cmax)

  From pre-dose Day 1 until Day 29

• Presence/absence of Anti-drug Antibodies

  From pre-dose Day 1 until Day 180

Study Arms (8)

Cohort 1

EXPERIMENTAL

Dose level 1

Drug: PIT565

Cohort 2

EXPERIMENTAL

Dose level 2

Drug: PIT565

Cohort 3

EXPERIMENTAL

Dose level 3

Drug: PIT565

Cohort 4

EXPERIMENTAL

Dose level 4

Drug: PIT565

Cohort 5

EXPERIMENTAL

Dose level 5

Drug: PIT565

Cohort 6

EXPERIMENTAL

Dose level 6

Drug: PIT565

Cohort 7

EXPERIMENTAL

Dose level 7

Drug: PIT565

Cohort 8

EXPERIMENTAL

Dose level 8

Drug: PIT565

Interventions

PIT565 DRUG

In each cohort, there will be 3 sentinel participants. Additional participants might be added depending on safety and observed biological activity.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Sofia, 1612, Bulgaria

WITHDRAWN

Novartis Investigative Site

Beijing, 100191, China

RECRUITING

Novartis Investigative Site

Beijing, 100730, China

RECRUITING

Novartis Investigative Site

Berlin, 10117, Germany

RECRUITING

Novartis Investigative Site

Mainz, 55131, Germany

RECRUITING

Novartis Investigative Site

Budapest, H-1083, Hungary

RECRUITING

Novartis Investigative Site

Szeged, 6725, Hungary

RECRUITING

Novartis Investigative Site

Leiden, South Holland, 2333 CL, Netherlands

RECRUITING

Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

RECRUITING

Novartis Investigative Site

Barcelona, 08035, Spain

RECRUITING

Novartis Investigative Site

Madrid, 28034, Spain

RECRUITING

Novartis Investigative Site

Bern, 3010, Switzerland

RECRUITING

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

WITHDRAWN

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1); CN (2); HU (2); CH (2); DE (2); ES (3); NL (1)