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New drug namilumab tested for lung sarcoidosis – but trial halted early

NCT ID NCT05314517

Disease control Sponsor: Kinevant Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested namilumab, an experimental drug, in 107 people with chronic pulmonary sarcoidosis, a condition causing lung inflammation. The trial was randomized and placebo-controlled, but it was terminated early. The goal was to see if namilumab could reduce the need for rescue treatments like steroids.

What this could mean

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

Active substance
namilumab
What this could lead to
If successful, namilumab could offer a new treatment option for chronic pulmonary sarcoidosis, potentially reducing the need for steroids.
What could go wrong
The trial was terminated early, so results are limited. It is a Phase 2 study, meaning it is still early and may not lead to an approved treatment.

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

107 people

The number who actually took part.

Started

Aug 2022

Finished

Apr 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 : * Male or female age ≥18 years * Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form * Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records * Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale \>1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET scan consistent with active pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease * Body Mass Index (BMI) ≤ 40 kg/m2 at Screening * Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization Exclusion Criteria * Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening * Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization * Hemoglobin ≤ 9.5 g/dL * Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study * ECG abnormalities that warrant further clinical investigation or management at Screening * Systolic blood pressure (SBP) \<90 or \>180mm Hg; Diastolic blood pressure (DBP) \<60 or \>110 mm Hg at Screening * Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization * Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry * Females who are pregnant or breastfeeding or intend to be during the course of the study * Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study * Subjects who are treatment naive Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

pulmonary sarcoidosis

As listed by the trial registrant

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

Sarcoidosis, pulmonary

Contacts and locations

Locations

  • Kinevant Study Site

    Birmingham, Alabama, 35233, United States

  • Kinevant Study Site

    Palo Alto, California, 94304, United States

  • Kinevant Study Site

    Valencia, California, 91355, United States

  • Kinevant Study Site

    Denver, Colorado, 80206, United States

  • Kinevant Study Site

    Gainesville, Florida, 32610, United States

  • Kinevant Study Site

    Augusta, Georgia, 29841, United States

  • Kinevant Study Site

    Chicago, Illinois, 60612, United States

  • Kinevant Study Site

    Iowa City, Iowa, 52242, United States

  • Kinevant Study Site

    Kansas City, Kansas, 66160, United States

  • Kinevant Study Site

    New Orleans, Louisiana, 70115, United States

  • Kinevant Study Site

    Baltimore, Maryland, 21234, United States

  • Kinevant Study Site

    Minneapolis, Minnesota, 55414, United States

  • Kinevant Study Site

    Rochester, Minnesota, 55905, United States

  • Kinevant Study Site

    Greenville, North Carolina, 27834, United States

  • Kinevant Study Site

    Cincinnati, Ohio, 45219, United States

  • Kinevant Study Site

    Cleveland, Ohio, 44195, United States

  • Kinevant Study Site

    Philadelphia, Pennsylvania, 19140, United States

  • Kinevant Study Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Kinevant Study Site

    Charleston, South Carolina, 29425, United States

  • Kinevant Study Site

    Rock Hill, South Carolina, 29732, United States

  • Kinevant Study Site

    Dallas, Texas, 75390, United States

  • Kinevant Study Site

    Houston, Texas, 77030, United States

  • Kinevant Study Site

    Charlottesville, Virginia, 22908, United States

  • Kinevant Study Site

    Falls Church, Virginia, 22042, United States

  • Kinevant Study Site

    Brussels, 1200, Belgium

  • Kinevant Study Site

    Leuven, 3000, Belgium

  • Kinevant Study Site

    Liège, B-4000, Belgium

  • Kinevant Study Site

    Yvoir, 5530, Belgium

  • Kinevant Study Site

    Bobigny, 93000, France

  • Kinevant Study Site

    Lille, 59037, France

  • Kinevant Study Site

    Paris, 75018, France

  • Kinevant Study Site

    Berlin, 14165, Germany

  • Kinevant Study Site

    Essen, 45239, Germany

  • Kinevant Study Site

    Freiburg im Breisgau, 79106, Germany

  • Kinevant Study Site

    Hanover, 30625, Germany

  • Kinevant Study Site

    Heidelberg, 69126, Germany

  • Kinevant Study Site

    Leiden, 2333 ZA, Netherlands

  • Kinevant Study Site

    Nieuwegein, 3435 CM, Netherlands

  • Kinevant Study Site

    Rotterdam, 3015 GD, Netherlands

  • Kinevant Study Site

    Ankara, 06620, Turkey (Türkiye)

  • Kinevant Study Site

    Istanbul, 34134, Turkey (Türkiye)

  • Kinevant Study Site

    Izmir, 35100, Turkey (Türkiye)

  • Kinevant Study Site

    Izmir, 35330, Turkey (Türkiye)

  • Kinevant Study Site

    Mersin, 33110, Turkey (Türkiye)

  • Kinevant Study Site

    Cambridge, CB20QQ, United Kingdom

  • Kinevant Study Site

    Cottingham, HU165JQ, United Kingdom

  • Kinevant Study Site

    London, SE59RS, United Kingdom

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