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New drug aims to halt lung decline in scarred lungs

NCT ID NCT06736990

Disease control Sponsor: Calluna Pharma AS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This trial tests an investigational drug called CAL101 in 150 adults with idiopathic pulmonary fibrosis, a disease that scars the lungs and makes breathing harder. Participants receive monthly IV infusions of CAL101 or a placebo for 6 months. The goal is to see if CAL101 can prevent further decline in lung function, measured by forced vital capacity (FVC).

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 150 people

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

Started

Jun 2025

Expected to finish

Feb 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

40 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: * ≥ 40 years of age * Diagnosis of IPF supported by centrally read chest high-resolution computed tomography * Definite or probable usual interstitial pneumonia (UIP) pattern on chest high-resolution computed tomography (HRCT) performed within 12 months of screening, confirmed by central review (if an evaluable HRCT \< 12 months is not available, the baseline HRCT will be used to determine eligibility). * FVC ≥ 45% of predicted (at Screening). * Diffusing capacity of the lung for carbon monoxide (DLCO) ≥ 25% predicted. * Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.70 at Screening or FEV1/FVC ≥ predicted value minus 0.10 (if predicted value according to the spirometry report at Screening is \<0.80). * Either stable dose with an approved antifibrotic for at least 8 weeks prior to screening or not treated with antifibrotics for at least 8 weeks prior to screening. Exclusion Criteria: * In the opinion of the Investigator, other clinically significant lung disease (e.g. asthma, emphysema, chronic obstructive pulmonary disease, cavitary or pleural diseases, clinically significant or treatment-requiring pulmonary hypertension) at screening. * Interstitial lung disease (ILD) other than IPF (including, but not limited to, connective tissue diseases, vasculitis). * Acute IPF exacerbation within 16 weeks prior to screening and/or during the screening period (investigator-determined). * Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period. * Evidence of impaired kidney function, unstable cardiovascular disease, moderate or severe hepatic impairment or any significant disease or condition other than IPF which may interfere with trial procedures or interpretation of trial results, or cause concern regarding the patient's ability to participate in the trial or any medical condition which could lead to a life expectancy \< 12months

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • AORN - Ospedali dei Colli - Ospedale V. Monaldi

    Naples, 80131, Italy

  • AP-HP Hopital Avicenne

    Bobigny, 93000, France

  • AP-HP Hopital Europeen Georges Pompidou

    Paris, 75015, France

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Akershus University Hospital

    Lørenskog, 1478, Norway

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedale - Università Padova

    Padova, PD, 35128, Italy

  • Azienda Ospedaliero Universitaria Senese

    Siena, SI, 53100, Italy

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124, Italy

  • Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara

    Trieste, TS, 34149, Italy

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • CHRU de Tours - Hôpital Bretonneau

    Tours, 37000, France

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35000, France

  • CHU de Toulouse - Hopital Larrey

    Toulouse, 31059 Cedex 9, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Ege University Medical Faculty Hospital

    Izmir, 35100, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, RM, 00168, Italy

  • Haukeland University Hospital

    Bergen, 5021, Norway

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Institutul de Pneumoftiziologie Marius Nasta

    Bucharest, 050159, Romania

  • Istituto Clinico Humanitas - Pneumologia 1

    Rozzano, 20089, Italy

  • Keck School of Medicine at USC

    Los Angeles, California, 90033, United States

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF, United Kingdom

  • Manchester University NHS Foundation Trust

    Manchester, M23 9QZ, United Kingdom

  • NHS Lothian, Edinburgh Royal Infirmary

    Edinburgh, EH16 4SA, United Kingdom

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Odense University Hospital

    Odense, 5000, Denmark

  • Oslo University Hospital, Rikshospitalet

    Oslo, 0372, Norway

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Pulmonix, LLC

    Greensboro, North Carolina, 27403, United States

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2GW, United Kingdom

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Royal Brompton Hospital

    London, SW3 6HP, United Kingdom

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie ''Victor Babes'' Craiova

    Craiova, Dolj, 200515, Romania

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie dr. Victor Babes Timisoara

    Timișoara, Timiș County, 300310, Romania

  • Spitalul Clinic de Pneumoftiziologie ''Leon Daniello''

    Cluj-Napoca, Cluj, 400371, Romania

  • St. Antonius Ziekenhuis - Locatie Nieuwegein

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • Uludag University Medical Faculty

    Bursa, 16059, Turkey (Türkiye)

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD, United Kingdom

  • University of Health Sciences Gulhane Faculty of Medicine

    Ankara, 06010, Turkey (Türkiye)

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Utah Health

    Salt Lake City, Utah, 84108, United States

  • Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research

    Miami, Florida, 33144, United States

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