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New pill for chronic hives and skin disease tested – but study halted early

NCT ID NCT06555328

Disease control Sponsor: InflaRx GmbH 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested an oral drug called INF904 in people with moderate to severe chronic spontaneous urticaria (long-term hives) or hidradenitis suppurativa (a painful skin condition). The trial was open-label and lasted 28 days of treatment plus follow-up. It aimed to check safety and how the drug moves through the body. However, the study was terminated early, so full results are not available.

What this could mean

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

Active substance
INF904 (an oral C5aR1 inhibitor)
What this could lead to
If successful, INF904 could offer a new oral treatment option for people with chronic hives or hidradenitis suppurativa.
What could go wrong
This was an early (Phase 2a) study that was terminated, so results are limited. The drug may not prove effective or safe in larger trials.

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

73 people

The number who actually took part.

Started

Jan 2025

Finished

Jan 2026

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 99 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: * Signed informed consent. * Subjects must be 18 years or older at the time of signing the informed consent. Exclusion Criteria: * Subjects with known severe or life-threatening hypersensitivity reaction to any other CSU/HS treatment according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE). * Subjects who have any other skin disease that may interfere with assessment of CSU or HS. * Subjects who have an active infection or history of infection(s) as follows: 1. Any infection requiring systemic treatment within 14 days prior to baseline. 2. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the subject. * Subjects with known progressed liver disease (Child-Pugh B or C)

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Conditions

The condition(s) this trial relates to.

chronic idiopathic urticaria Chronic Urticaria hidradenitis hidradenitis suppurativa

As listed by the trial registrant

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

Chronic urticaria, idiopathic Hidradenitis Hidradenitis suppurativa

Contacts and locations

Locations

  • "Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska"

    Wroclaw, 50-566, Poland

  • "Institut Allergieforschung Charité - Universitatsmedizin Berlin"

    Berlin, 12203, Germany

  • "Klinikum der Universitat (LMU) Klinik und Poliklinik far Dermatologie und Allergologie"

    München, 80337, Germany

  • ASMC IPSMC Skin and Venereal Diseases,

    Sofia, 1407, Bulgaria

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • First OC Dermatology Research Inc.

    Fountain Valley, California, 92708, United States

  • ForCare Clinical Research

    Tampa, Florida, 33613, United States

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11415, United States

  • General Hospital of Thessaloniki "Papageorgiou"

    Thessaloniki, 56403, Greece

  • General University Hospital "Attikon"

    Athens, 12462, Greece

  • Katholisches Klinikum Bochum gGmbH/ St.Josef-Hospital Bochum, Dermatologie

    Bochum, 44791, Germany

  • Kentucky Advanced Medical Research LLC

    Murray, Kentucky, 42071, United States

  • Klinika Dermatologii, Wenerologii i Alergologii, UNIWERSYTECKIE CENTRUM KLINICZNE, ul.

    Gdansk, 80-214, Poland

  • LLC "Aversi Clinic"

    Tbilisi, 0160, Georgia

  • LLC "Center of Allergy and Immunology"

    Tbilisi, 0159, Georgia

  • LTD "Health"

    Batumi, 6010, Georgia

  • LTD "Israel-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112, Georgia

  • Labderm Essence sp.

    Ossy, 42-624, Poland

  • MediSearch LLC

    Saint Joseph, Missouri, 64506, United States

  • Medical Center Etika

    Plovdiv, 4200, Bulgaria

  • Medical Center Excelsior OOD,

    Sofia, 1407, Bulgaria

  • Medical Center Medconsult pleven OOD

    Pleven, 5800, Bulgaria

  • Medical Center Medconsult, Pleven OOD

    Lovech, 5500, Bulgaria

  • Oddziat Kliniczny Wewnetrznych, Astmy i Alergii z Odcinkiem dla Dzieci, Samodzielny Publiczny Zaktad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny

    Lodz, 90-153, Poland

  • Progressive Clinical Research, PA

    Texas City, Texas, 78213, United States

  • Universitatsklinikum Dresden Carl Gustav Carus

    Dresden, 01307, Germany

  • Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie

    Frankfurt, 60950, Germany

  • Wright State Physicians

    Fairborn, Ohio, 45324, United States

  • Ziaderm Research LLC

    North Miami Beach, Florida, 33162, United States

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