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

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• ≥ 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.

Locations
United States
California
Keck School of Medicine at USC
RECRUITING
Los Angeles
Colorado
National Jewish Health
RECRUITING
Denver
Florida
Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research
RECRUITING
Miami
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
North Carolina
Pulmonix, LLC
RECRUITING
Greensboro
Southeastern Research Center
RECRUITING
Winston-salem
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
Utah
University of Utah Health
RECRUITING
Salt Lake City
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
France
AP-HP Hopital Avicenne
NOT_YET_RECRUITING
Bobigny
AP-HP Hopital Europeen Georges Pompidou
NOT_YET_RECRUITING
Paris
CHU Rennes - Hopital Pontchaillou
NOT_YET_RECRUITING
Rennes
CHU de Toulouse - Hopital Larrey
RECRUITING
Toulouse
CHRU de Tours - Hôpital Bretonneau
RECRUITING
Tours
Italy
Azienda Ospedaliero-Universitaria di Modena
NOT_YET_RECRUITING
Modena
AORN - Ospedali dei Colli - Ospedale V. Monaldi
RECRUITING
Napoli
Azienda Ospedale - Università Padova
RECRUITING
Padua
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
RECRUITING
Roma
Istituto Clinico Humanitas - Pneumologia 1
NOT_YET_RECRUITING
Rozzano
Azienda Ospedaliero Universitaria Senese
RECRUITING
Siena
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
RECRUITING
Trieste
Netherlands
St. Antonius Ziekenhuis - Locatie Nieuwegein
RECRUITING
Nieuwegein
Erasmus MC
RECRUITING
Rotterdam
Norway
Haukeland University Hospital
RECRUITING
Bergen
Akershus University Hospital
RECRUITING
Lørenskog
Oslo University Hospital, Rikshospitalet
RECRUITING
Oslo
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Gyeonggi-do
Asan Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Romania
Institutul de Pneumoftiziologie Marius Nasta
RECRUITING
Bucharest
Spitalul Clinic de Pneumoftiziologie ''Leon Daniello''
RECRUITING
Cluj-napoca
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie ''Victor Babes'' Craiova
RECRUITING
Craiova
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie dr. Victor Babes Timisoara
RECRUITING
Timișoara
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Clinico Universitario de Santiago
RECRUITING
Santiago De Compostela
Turkey
University of Health Sciences Gulhane Faculty of Medicine
RECRUITING
Ankara
Uludag University Medical Faculty
RECRUITING
Bursa
Ege University Medical Faculty Hospital
RECRUITING
Izmir
United Kingdom
Birmingham Heartlands Hospital
NOT_YET_RECRUITING
Birmingham
Queen Elizabeth Hospital Birmingham
NOT_YET_RECRUITING
Birmingham
NHS Lothian, Edinburgh Royal Infirmary
RECRUITING
Edinburgh
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Royal Brompton Hospital
RECRUITING
London
Manchester University NHS Foundation Trust
RECRUITING
Manchester
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
Charlotte Kleiveland
info@callunapharma.com
+4740857584
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2027-11
Participants
Target number of participants: 150
Treatments
Experimental: CAL101
Placebo_comparator: Placebo
Sponsors
Leads: Calluna Pharma AS

This content was sourced from clinicaltrials.gov

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