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New lupus drug PIT565 enters human safety trials

NCT ID NCT06335979

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called PIT565 in about 54 people with active lupus who have not gotten better with standard treatments. The main goal is to see if the drug is safe and how the body processes it. Participants will receive increasing doses of the drug and be closely monitored for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus (SLE)

Contacts and locations

Locations

  • Novartis Investigative Site

    Beijing, 100191, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Berlin, 10117, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    Szeged, 6725, Hungary

  • Novartis Investigative Site

    Leiden, South Holland, 2333 CL, Netherlands

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Bern, 3010, Switzerland

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