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Experimental drug HZN-825 tested for rare autoimmune lung complication

NCT ID NCT05626751

Disease control Sponsor: Amgen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tested the drug HZN-825 in 174 people with diffuse cutaneous systemic sclerosis, a rare autoimmune disease that can scar the lungs. Participants took the drug twice daily for 52 weeks to see if it helped maintain lung function and to check for side effects. The study was terminated early, so the 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
HZN-825
What this could lead to
If successful, this could point toward a treatment option to help manage lung function decline in people with diffuse cutaneous systemic sclerosis.
What could go wrong
This trial was terminated early, so results are limited. It was also an open-label extension without a placebo group, making it harder to confirm true benefits.

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

174 people

The number who actually took part.

Started

Nov 2022

Finished

Feb 2025

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.

Key Inclusion Criteria: 1\. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; participants prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments. Key Exclusion Criteria: 1. Anticipated use of another investigational agent for any condition during the course of the trial. 2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 3. Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol. 4. Any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk. 5. Pregnant or lactating women. 6. Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma systemic sclerosis

As listed by the trial registrant

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

Diffuse cutaneous systemic sclerosis Sclerosis, systemic

Contacts and locations

Locations

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    Buenos Aires, C1406AGA, Argentina

  • Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

    Phoenix, Arizona, 85032-9306, United States

  • Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia

    Udine, Friuli Venezia Giulia, 33100, Italy

  • Boston University School Of Medicine

    Boston, Massachusetts, 02118-2642, United States

  • CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV

    México, 6700, Mexico

  • Centro Integral Reumatologia SA de CV

    Guadalajara, Jalisco, ZC 44160, Mexico

  • Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

    Burócratas Del Estado, San Luis Potosí, 78213, Mexico

  • Centro de Estudios de Investigacion Basica Y Clinica SC

    Guadalajara, Jalisco, 44690, Mexico

  • Centro de Investigaciones Médicas Tucumán - PPDS

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Centro de Investigaciones Reumatológicas

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • Centro de Investigación y Tratamiento Reumatológico S.C

    San Miguel Chapultepec, Mexico City, 11850, Mexico

  • Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

    Brasov, 500283, Romania

  • Centrum Medyczne Reuma Park NZOZ

    Warsaw, Masovian Voivodeship, 02-665, Poland

  • Chonnam National University Hospital

    Gwangju, Gwangju Gwang'yeogsi, 61469, South Korea

  • Clinica de Investigacion en Reumatologia y Obesidad

    Guadalajara, 44600, Mexico

  • Clínica Adventista Belgrano

    Cuiudad Autónoma de Buenos Aires, C1430EGF, Argentina

  • Clínica Mayo de U.M.C.B. S.R.L

    San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

  • Consultorio Médico Dra. Rivera

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426, Argentina

  • DelRicht Clinical Research, LLC - Internal - Covington - PPDS

    New Orleans, Louisiana, 70115-3584, United States

  • Dr I Cantacuzino Clinical Hospital

    Bucharest, Bucharest, 20475, Romania

  • Duke University Medical Center

    Durham, North Carolina, 27710-3037, United States

  • Euromedica Kianous Stavros

    Thessaloniki, 546 36, Greece

  • Framingham Centro Médico

    La Plata, Buenos Aires, B1900, Argentina

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273, South Korea

  • General Hospital of Thessaloniki ''Hippokratio''

    Thessaloniki, 546 42, Greece

  • Hanyang University Seoul Hospital

    Seongdong-gu, Seoul Teugbyeolsi, 04763, South Korea

  • Hokkaido University Hospital

    Sapporo, Hokkaidô, 060-848, Japan

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009, Spain

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010, Spain

  • Hospital Universitario A Coruña

    A Coruña, 15006, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS

    Lisbon, 1649-035, Portugal

  • I.R. Medical Center - Hospital de Dia

    Mendoza, M5500CPH, Argentina

  • IRIS Research and Development LLC

    Plantation, Florida, 33324-2736, United States

  • Institute for Treatment and Rehabilitation Niska Banja

    Niška Banja, 708120, Serbia

  • Institute of Rheumatology - PPDS

    Belgrade, 11000, Serbia

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico City, 14000, Mexico

  • Juntendo University Hospital

    Bunkyo-Ku, Tokyo, 113-8431, Japan

  • Laiko General Hospital of Athens

    Athens, Attica, 115 27, Greece

  • Malopolskie Centrum Kliniczne

    Krakow, Lesser Poland Voivodeship, 30-149, Poland

  • Mayo Clinic - Cancer Center - Rochester - PPDS

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina (MUSC) - PPDS

    Charleston, South Carolina, 29425-8900, United States

  • Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • Michigan Medicine University of Michigan

    Ann Arbor, Michigan, 48109-5000, United States

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8102, Japan

  • Nippon Medical School Hospital

    Bunkyo-Ku, Tokyo, 113-8603, Japan

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-Shi, Ôsaka, 569-8686, Japan

  • Prosalud y Cia Ltda.

    Santiago, Región-MetropolitanadeSantiago, 7510047, Chile

  • Rabin Medical Center - PPDS

    Petah Tikva, 4910000, Israel

  • Rambam Health Care Campus - PPDS

    Haifa, 31096, Israel

  • Royal Free Hospital

    London, London, City of, NW3 2QG, United Kingdom

  • Saitama Medical University Hospital

    Iruma-Gun, Saitama, 350-0495, Japan

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô, 060-8543, Japan

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggido, 13620, South Korea

  • Sf.Maria Clinical Hospital

    Bucharest, Bucharest, 011172, Romania

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    Tel Aviv, Tel Aviv, 64239, Israel

  • The Chaim Sheba Medical Center - PPDS

    Ramat Gan, Tel Aviv, 52621, Israel

  • Twoja Przychodnia NCM

    Nowa Sól, Lubusz Voivodeship, 67-100, Poland

  • UCLA Medical Center

    Los Angeles, California, 90095-8344, United States

  • UT Physicians Rheumatology

    Houston, Texas, 77030-5400, United States

  • Unidad de Atencion Medica e Investigacion en Salud

    Mérida, 97000, Mexico

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136-1005, United States

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