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New drug aims to cut steroid use in lung sarcoidosis

NCT ID NCT05415137

Disease control Sponsor: aTyr Pharma, 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a drug called efzofitimod in 268 adults with pulmonary sarcoidosis, a condition that causes lung inflammation. Participants received either the drug or a placebo every 4 weeks for 48 weeks. The main goal was to see if the drug could help people safely reduce their daily steroid dose while controlling their disease.

What this could mean

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

Active substance
efzofitimod (also called ATYR1923 or KRP-R120)
What this could lead to
If it works, this could help people with pulmonary sarcoidosis reduce their reliance on steroids while keeping symptoms under control.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. It may not show a meaningful benefit over placebo, and side effects from the drug are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

268 people

The number who actually took part.

Started

Sep 2022

Finished

Jul 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 years and older

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: * Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence * Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70 * Patients must be receiving treatment with OCS of ≥ 3 months at Day 1 with a starting dose between ≥ 7.5 and ≤ 25 mg/day ≥ 4 weeks prior to Day 1. * Body weight ≥ 40 kg and \< 160 kg Exclusion Criteria: * Treatment with \> 1 immunosuppressant therapy * Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors * Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis \> 20% within the last 12 months; FVC percent predicted (FVCPP) \< 50% and KSQ-Lung score \< 30 * In the opinion of the investigator, clinically significant pulmonary hypertension * Patients with active cardiac, neuro, or renal sarcoidosis requiring organ-specific therapy in the past 2 years * Patients with cutaneous or ocular sarcoidosis, which in the opinion of the Investigator, are at risk for exacerbation, necessitating OCS rescue or other systemic therapy * History of Addisonian symptoms that precluded previous OCS taper attempts * Is an active, heavy smoker of tobacco/nicotine-containing products * History of anti-synthetase syndrome or Jo-1 positive at Screening * Patients with active tuberculosis or those currently undergoing treatment for tuberculosis

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Conditions

The condition(s) this trial relates to.

Fibrosis Granuloma Inflammation interstitial lung disease lymphoproliferative syndrome pulmonary sarcoidosis sarcoidosis

As listed by the trial registrant

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

Pulmonary sarcoidosis

Contacts and locations

Locations

  • Kyorin Investigative Site

    Aomori, 036-8563, Japan

  • Kyorin Investigative Site

    Fukuoka, 814-0180, Japan

  • Kyorin Investigative Site

    Fukushima, 960-1295, Japan

  • Kyorin Investigative Site

    Hokkaido, 060-0033, Japan

  • Kyorin Investigative Site

    Hokkaido, 060-8648, Japan

  • Kyorin Investigative Site

    Hyōgo, 653-0013, Japan

  • Kyorin Investigative Site

    Kanagawa, 236-0004, Japan

  • Kyorin Investigative Site

    Kanagawa, 236-0051, Japan

  • Kyorin Investigative Site

    Miyagi, 980-8574, Japan

  • Kyorin Investigative Site

    Okayama, 700-8558, Japan

  • Kyorin Investigative Site

    Osaka, 591-8025, Japan

  • Kyorin Investigative Site

    Shimane, 693-8501, Japan

  • Kyorin Investigative Site

    Shizuoka, 431-3192, Japan

  • Kyorin Investigative Site

    Tokyo, 150-8935, Japan

  • Kyorin Investigative Site

    Tokyo, 151-8528, Japan

  • aTyr Investigative Site

    Birmingham, Alabama, 35294, United States

  • aTyr Investigative Site

    Phoenix, Arizona, 85027, United States

  • aTyr Investigative Site

    Los Angeles, California, 90033, United States

  • aTyr Investigative Site

    Sacramento, California, 95817, United States

  • aTyr Investigative Site

    Denver, Colorado, 80206, United States

  • aTyr Investigative Site

    Washington D.C., District of Columbia, 20060, United States

  • aTyr Investigative Site

    Gainesville, Florida, 32610, United States

  • aTyr Investigative Site

    Tampa, Florida, 33606, United States

  • aTyr Investigative Site

    Weston, Florida, 33331, United States

  • aTyr Investigative Site

    Atlanta, Georgia, 30308, United States

  • aTyr Investigative Site

    Chicago, Illinois, 60611, United States

  • aTyr Investigative Site

    Chicago, Illinois, 60612, United States

  • aTyr Investigative Site

    Louisville, Kentucky, 40202, United States

  • aTyr Investigative Site

    New Orleans, Louisiana, 70115, United States

  • aTyr Investigative Site

    Baltimore, Maryland, 21224, United States

  • aTyr Investigative Site

    Boston, Massachusetts, 02114, United States

  • aTyr Investigative Site

    Ada, Michigan, 49301, United States

  • aTyr Investigative Site

    Detroit, Michigan, 48202, United States

  • aTyr Investigative Site

    Minneapolis, Minnesota, 55455, United States

  • aTyr Investigative Site

    Rochester, Minnesota, 55905, United States

  • aTyr Investigative Site

    Jackson, Mississippi, 39216, United States

  • aTyr Investigative Site

    St Louis, Missouri, 63110, United States

  • aTyr Investigative Site

    Albany, New York, 12208, United States

  • aTyr Investigative Site

    Middletown, New York, 10941, United States

  • aTyr Investigative Site

    Durham, North Carolina, 27710, United States

  • aTyr Investigative Site

    Greenville, North Carolina, 27834, United States

  • aTyr Investigative Site

    Cincinnati, Ohio, 45219, United States

  • aTyr Investigative Site

    Cleveland, Ohio, 44195, United States

  • aTyr Investigative Site

    Oklahoma City, Oklahoma, 73104, United States

  • aTyr Investigative Site

    Portland, Oregon, 97220, United States

  • aTyr Investigative Site

    Philadelphia, Pennsylvania, 19140, United States

  • aTyr Investigative Site

    Charleston, South Carolina, 29425-0630, United States

  • aTyr Investigative Site

    Dickson, Tennessee, 37055, United States

  • aTyr Investigative Site

    Dallas, Texas, 75246, United States

  • aTyr Investigative Site

    Dallas, Texas, 75390, United States

  • aTyr Investigative Site

    Houston, Texas, 77030, United States

  • aTyr Investigative Site

    Salt Lake City, Utah, 84132, United States

  • aTyr Investigative Site

    Falls Church, Virginia, 22042, United States

  • aTyr Investigative Site

    Richmond, Virginia, 23298, United States

  • aTyr Investigative Site

    Salvador, Estado de Bahia, 40220-005, Brazil

  • aTyr Investigative Site

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • aTyr Investigative Site

    São Bernardo do Campo, 09780-000, Brazil

  • aTyr Investigative Site

    São Paulo, 04039-901, Brazil

  • aTyr Investigative Site

    São Paulo, 05403-900, Brazil

  • aTyr Investigative Site

    Bobigny, 93000, France

  • aTyr Investigative Site

    La Tronche, 38700, France

  • aTyr Investigative Site

    Montpellier, 34295, France

  • aTyr Investigative Site

    Paris, 75015, France

  • aTyr Investigative Site

    Toulouse, 31000, France

  • aTyr Investigative Site

    Essen, 45122, Germany

  • aTyr Investigative Site

    Freiburg im Breisgau, 79106, Germany

  • aTyr Investigative Site

    Hanover, 30625, Germany

  • aTyr Investigative Site

    Heidelberg, 69126, Germany

  • aTyr Investigative Site

    Catania, 95124, Italy

  • aTyr Investigative Site

    Florence, 50134, Italy

  • aTyr Investigative Site

    Forlì, 47121, Italy

  • aTyr Investigative Site

    Milan, 20123, Italy

  • aTyr Investigative Site

    Naples, 80131, Italy

  • aTyr Investigative Site

    Padua, 35128, Italy

  • aTyr Investigative Site

    Rome, 00168, Italy

  • aTyr Investigative Site

    Siena, 53100, Italy

  • aTyr Investigative Site

    Trieste, 34149, Italy

  • aTyr Investigative Site

    Kumamoto, 860-8556, Japan

  • aTyr Investigative Site

    Nieuwegein, 3435CM, Netherlands

  • aTyr Investigative Site

    Barcelona, 08036, Spain

  • aTyr Investigative Site

    Barcelona, 08907, Spain

  • aTyr Investigative Site

    Madrid, 28006, Spain

  • aTyr Investigative Site

    Madrid, 28031, Spain

  • aTyr Investigative Site

    Santander, 39008, Spain

  • aTyr Investigative Site

    Valencia, 46010, Spain

  • aTyr Investigative Site

    Birmingham, B15 2TH, United Kingdom

  • aTyr Investigative Site

    Cambridge, CB233RE, United Kingdom

  • aTyr Investigative Site

    Cottingham, HU16 5JQ, United Kingdom

  • aTyr Investigative Site

    Coventry, CV2 2DX, United Kingdom

  • aTyr Investigative Site

    London, SE59RS, United Kingdom

  • aTyr Investigative Site

    London, SW3 6NP, United Kingdom

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