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RECRUITING
NCT06736990
PHASE2

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

Sponsor: Calluna Pharma AS

View on ClinicalTrials.gov

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.

Official title: A Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of CAL101 in Patients With Idiopathic Pulmonary Fibrosis

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-06-20

Completion Date

2027-11

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

CAL101

Intravenous infusions of CAL101 every 4 weeks over 24 weeks

DRUG

Placebo

Intravenous infusions of placebo every 4 weeks over 24 weeks

Locations (54)

Keck School of Medicine at USC

Los Angeles, California, United States

National Jewish Health

Denver, Colorado, United States

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

Miami, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Pulmonix, LLC

Greensboro, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Utah Health

Salt Lake City, Utah, United States

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

AP-HP Hopital Avicenne

Bobigny, France

AP-HP Hopital Europeen Georges Pompidou

Paris, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

CHU de Toulouse - Hopital Larrey

Toulouse, France

CHRU de Tours - Hôpital Bretonneau

Tours, France

Azienda Ospedale - Università Padova

Padova, PD, Italy

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

Roma, RM, Italy

Azienda Ospedaliero Universitaria Senese

Siena, SI, Italy

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

Trieste, TS, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

AORN - Ospedali dei Colli - Ospedale V. Monaldi

Naples, Italy

Istituto Clinico Humanitas - Pneumologia 1

Rozzano, Italy

Erasmus MC

Rotterdam, South Holland, Netherlands

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, Utrecht, Netherlands

Haukeland University Hospital

Bergen, Norway

Akershus University Hospital

Lørenskog, Norway

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Spitalul Clinic de Pneumoftiziologie ''Leon Daniello''

Cluj-Napoca, Cluj, Romania

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

Craiova, Dolj, Romania

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

Timișoara, Timiș County, Romania

Institutul de Pneumoftiziologie Marius Nasta

Bucharest, Romania

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

University of Health Sciences Gulhane Faculty of Medicine

Ankara, Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, Turkey (Türkiye)

Ege University Medical Faculty Hospital

Izmir, Turkey (Türkiye)

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Birmingham Heartlands Hospital

Birmingham, United Kingdom

NHS Lothian, Edinburgh Royal Infirmary

Edinburgh, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Royal Brompton Hospital

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom