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New antibody drug aims to calm painful skin condition

NCT ID NCT06993610

Disease control Sponsor: Zura Bio Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 2 trial tests tibulizumab, a dual-action antibody, in 225 adults with hidradenitis suppurativa (HS), a chronic skin condition causing painful abscesses. Participants first receive either the drug or a placebo for 16 weeks, then everyone gets the drug for another 16 weeks. The goal is to see if tibulizumab reduces the number of abscesses and inflammatory nodules.

What this could mean

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

Active substance
tibulizumab (an antibody that targets BAFF and IL-17 to reduce inflammation)
What this could lead to
If successful, this could provide a new treatment option for hidradenitis suppurativa, potentially reducing painful flare-ups and improving quality of life.
What could go wrong
This is an early Phase 2 trial with only 225 participants, so results may not apply to everyone. The drug may cause side effects or fail to show significant benefit over placebo.
Why investors are watching

Zura Bio, a very small publicly traded company, is running a Phase 2 trial of its drug tibulizumab in 225 adults with hidradenitis suppurativa, a painful skin condition. The trial has a 16-week placebo-controlled period followed by a 16-week open-label period where everyone gets the drug. For a micro-cap company with few products, this readout is a major test of whether tibulizumab works and whether the company has a viable future.

If it works: If tibulizumab shows clear benefit over placebo, Zura Bio could have a promising drug candidate for a disease with few treatment options. That result could attract partners or funding to move the drug into later-stage trials.

If it fails: Phase 2 trials fail often, and tibulizumab may not beat placebo. A failure or delay could leave Zura Bio without a lead product and make it hard for the company to raise money.

AI-written from the trial record. Speculative, and not investment advice.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 225 people

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

Started

May 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 70 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: * Male or female, 18 to 70 years of age * ≥6-month history of Hidradenitis suppurativa (HS) * Total AN (abscess and inflammatory nodule) count ≥5 * HS lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III Exclusion Criteria: * Draining tunnel count \>20 * Presence of another inflammatory condition or a skin condition that may interfere with study assessments * Known to have immune deficiency or is immunocompromised * Evidence or suspicion of active or latent tuberculosis * History of opportunistic, chronic, or recurrent infection requiring chronic antibiotic use, serious or life-threatening infection within 2 months, or had an infection requiring systemic antibiotics within 2 weeks * Has active systemic candidiasis * Unable to tolerate subcutaneous drug administration

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Conditions

The condition(s) this trial relates to.

Acne Vulgaris dermatitis hidradenitis hidradenitis suppurativa skin disease caused by bacterial infection skin disorder sweat gland disorder

As listed by the trial registrant

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

Hidradenitis suppurativa (HS)

Contacts and locations

Locations

  • Apex Clinical Research Center

    Mayfield Heights, Ohio, 44124, United States

  • BRCR Global Texas

    Katy, Texas, 77450, United States

  • Best Skin Research LLC

    Camp Hill, Pennsylvania, 17011, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Centre de recherche Saint-Louis

    Québec, Quebec, G1W 4R4, Canada

  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp z .o.o

    Malbork, 82200, Poland

  • ClinOhio Research Services

    Columbus, Ohio, 43213, United States

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006, United States

  • DS Research of Kentucky, LLC

    Louisville, Kentucky, 40241, United States

  • DelRicht LLC

    Baton Rouge, Louisiana, 70809, United States

  • DelRicht Research

    Mt. Pleasant, South Carolina, 29464, United States

  • DelRicht Research

    Prosper, Texas, 75078, United States

  • Dermatology Specialists of Spokane

    Spokane, Washington, 99202, United States

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230, United States

  • Edificio IMIBIC, Reina Sofia University Hospital

    Córdoba, 14004, Spain

  • Equity Medical

    New York, New York, 10023, United States

  • Equity Medical LLC (Kentucky)

    Bowling Green, Kentucky, 42104, United States

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455, Germany

  • First OC Dermatology Research, Inc.

    Irvine, California, 92614, United States

  • Florida Academic Dermatology Center

    Coral Gables, Florida, 33134, United States

  • Frontier Dermatology

    Mill Creek, Washington, 98012, United States

  • Georgia Skin & Cancer Clinic

    Savannah, Georgia, 31419, United States

  • Gregorio Marañón General University Hospital

    Madrid, 28007, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee, 37130, United States

  • Katholische Klinikum Bochum gGmbH

    Bochum, 44791, Germany

  • Klinik und Poliklinik für Dermatologie und Allergologie

    München, 80337, Germany

  • Klinikum Darmstadt

    Darmstadt, 64283, Germany

  • Laser Clinic S.C.

    Szczecin, 70-332, Poland

  • Manufaktura Zdrowia i Urody

    Warsaw, 02-922, Poland

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506, United States

  • Medical Dermatology Specialists (Phoenix)

    Phoenix, Arizona, 85006, United States

  • NorCal Clinical Research

    Rocklin, California, 95765, United States

  • North York Research Inc

    North York, Ontario, M2J 5B2, Canada

  • Northridge Clinical Trials

    Northridge, California, 91325, United States

  • OptiSkin Medical

    New York, New York, 10128, United States

  • Optima Research

    Boardman, Ohio, 44512, United States

  • Palmetto Clinical Trial Services

    Anderson, South Carolina, 29625, United States

  • Progressive Clinical Research

    San Antonio, Texas, 78213, United States

  • Provita Centrum Medyczne Sp. z o.o. Katowice

    Katowice, 40-611, Poland

  • Provita Sp. z o. o.

    Katowice, 40-611, Poland

  • RENEW Clinic

    Bialystok, 15-797, Poland

  • Red River Research Partners

    Fargo, North Dakota, 58103, United States

  • Ryan Clinical Research Inc.

    Newmarket, Ontario, L3Y 5G8, Canada

  • SOLUMED

    Poznan, 60-425, Poland

  • Saskatoon Dermatology Centre

    Saskatoon, Saskatchewan, S7T 0G3, Canada

  • Semmelweis University

    Budapest, 1085, Hungary

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509, United States

  • Skin Care Research, LLC

    Hollywood, Florida, 33021, United States

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168, United States

  • University Clinic Dermatology Heidelberg

    Heidelberg, 69120, Germany

  • University Hospital Dresden

    Dresden, 01307, Germany

  • University Hospital Muenster - Münster

    Münster, 48149, Germany

  • University of Debrecen

    Debrecen, 4032, Hungary

  • University of Szeged

    Szeged, 6720, Hungary

  • University of Washington Medical Center

    Seattle, Washington, 98164, United States

  • Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)

    Hamburg, 20251, Germany

  • Wallace Medical Group, Inc.

    Los Angeles, California, 90056, United States

  • York Dermatology Clinic & Research Centre

    Richmond Hill, Ontario, L4B 1L1, Canada

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