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New lupus drug candidate enters first human tests

NCT ID NCT07011043

Disease control Sponsor: Climb Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial is testing a new drug called budoprutug (TNT119) in 30 adults with active systemic lupus erythematosus (SLE). The main goal is to check the drug's safety and how the body processes it. Participants will receive a single dose of the drug by IV, and researchers will monitor them for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
budoprutug (TNT119)
What this could lead to
If this drug is safe and shows promise, it could lead to a new treatment option for people with active lupus who haven't responded well to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 30 participants, focused mainly on safety. It is too small and early to know if the drug will effectively treat lupus or have serious 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 30 people

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

Started

Jul 2025

Expected to finish

Apr 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 65 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: 1. Aged 18 to 65 years at the time of consent. 2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria. 3. Active, seropositive disease, with SLEDAI 2K \>=8. 4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy. Exclusion Criteria: 1. Active neuropsychiatric SLE. 2. History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation. 3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Climb Bio Investigative Site #100101

    RECRUITING

    San Antonio, Texas, 78215, United States

  • Climb Bio Investigative Site #100103

    RECRUITING

    Caguas, Puerto Rico

  • Climb Bio Investigative Site #100104

    RECRUITING

    Allen, Texas, 75013, United States

  • Climb Bio Investigative Site #380101

    RECRUITING

    Ternopil, Ukraine

  • Climb Bio Investigative Site #380102

    RECRUITING

    Ivano-Frankivsk, Ukraine

  • Climb Bio Investigative Site #380103

    RECRUITING

    Kyiv, Ukraine

  • Climb Bio Investigative Site #380104

    RECRUITING

    Vinnytsia, Ukraine

  • Climb Bio Investigative Site #380105

    RECRUITING

    Vinnytsia, Ukraine

  • Climb Bio Investigative Site #380106

    RECRUITING

    Kyiv, Ukraine

  • Climb Bio Investigative Site #995101

    RECRUITING

    Tbilisi, 0141, Georgia

  • Climb Bio Investigative Site #995102

    RECRUITING

    Tbilisi, 0112, Georgia

  • Climb Bio Investigative Site# 300102

    RECRUITING

    Exochi, Thessaloniki, 57010, Greece

  • Climb Bio Investigative Site# 300103

    RECRUITING

    Thessaloniki, Thessaloniki, 54642, Greece

  • Climb Bio Investigative Site# 340101

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Climb Bio Investigative Site# 340102

    RECRUITING

    A Coruña, 15006, Spain

  • Climb Bio Investigative Site# 359101

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Climb Bio Investigative Site# 359102

    RECRUITING

    Sofia, 1618, Bulgaria

  • Climb Bio Investigative Site# 400101

    RECRUITING

    Cluj-Napoca, 400006, Romania

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