A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis

NCT06736990 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: CAL101-2012024-518339-12-00
• Study Type: interventional
• Target: 150
• Locations: 11 countries
• Sites: 54

Brief Summary

The goal of this clinical trial is to learn if the investigational drug CAL101 can help prevent further decline in lung function in adults with Idiopathic Pulmonary Fibrosis. Researchers will compare CAL101 with placebo to compare change from baseline in forced vital capacity (FVC). Participants will be randomly assigned to a study group that will receive an IV infusion of either the study medication or placebo about once a month for 6 months.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in forced vital capacity (FVC) compared to placebo

  28 weeks

Study Arms (2)

CAL101

EXPERIMENTAL

Drug: CAL101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CAL101 DRUG

Intravenous infusions of CAL101 every 4 weeks over 24 weeks

CAL101

Placebo DRUG

Intravenous infusions of placebo every 4 weeks over 24 weeks

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Calluna Pharma AS: lead

Study Sites (54)

Keck School of Medicine at USC

Los Angeles, California, 90033, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

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

Miami, Florida, 33144, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Pulmonix, LLC

Greensboro, North Carolina, 27403, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Utah Health

Salt Lake City, Utah, 84108, United States

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

AP-HP Hopital Avicenne

Bobigny, 93000, France

Location

AP-HP Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

CHU Rennes - Hopital Pontchaillou

Rennes, 35000, France

Location

CHU de Toulouse - Hopital Larrey

Toulouse, 31059 Cedex 9, France

Location

CHRU de Tours - Hôpital Bretonneau

Tours, 37000, France

Location

Azienda Ospedale - Università Padova

Padova, PD, 35128, Italy

Location

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

Roma, RM, 00168, Italy

Location

Azienda Ospedaliero Universitaria Senese

Siena, SI, 53100, Italy

Location

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

Trieste, TS, 34149, Italy

Location

Azienda Ospedaliero-Universitaria di Modena

Modena, 41124, Italy

Location

AORN - Ospedali dei Colli - Ospedale V. Monaldi

Naples, 80131, Italy

Location

Istituto Clinico Humanitas - Pneumologia 1

Rozzano, 20089, Italy

Location

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, 0372, Norway

Location

Spitalul Clinic de Pneumoftiziologie ''Leon Daniello''

Cluj-Napoca, Cluj, 400371, Romania

Location

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

Craiova, Dolj, 200515, Romania

Location

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

Timișoara, Timiș County, 300310, Romania

Location

Institutul de Pneumoftiziologie Marius Nasta

Bucharest, 050159, Romania

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

University of Health Sciences Gulhane Faculty of Medicine

Ankara, 06010, Turkey (Türkiye)

Location

Uludag University Medical Faculty

Bursa, 16059, Turkey (Türkiye)

Location

Ege University Medical Faculty Hospital

Izmir, 35100, Turkey (Türkiye)

Location

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

NHS Lothian, Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6HP, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M23 9QZ, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Borchert SV, Hallen J, Hussain RI, Holyer I, Troelsen JT, Klingelhofer J. Development of CAL101-a humanized monoclonal antibody targeting S100A4 to inhibit proinflammatory and profibrotic signaling. J Pharmacol Exp Ther. 2025 Nov;392(11):103722. doi: 10.1016/j.jpet.2025.103722. Epub 2025 Sep 24.

  PMID: 41124966 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 17, 2024
• Study Start: June 20, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); DK (3); KR (5); NL (2); GB (9); TU (3); RO (4); IT (7); ES (4); FR (5); NO (3)