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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: CAL101; Drug: Placebo

Detailed Description

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CAL101 in participants with IPF, either as standalone treatment or in addition to currently approved antifibrotic treatments..

The study will consist of a 28-days Screening Period, intravenous (IV) infusions of CAL101 or placebo once every 4 weeks over 24 weeks, and a 16 week Follow-up Period.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Odense, Denmark, 5000
    • Odense University Hospital
• France
  • Bobigny, France, 93000
    • AP-HP Hôpital Avicenne
  • Paris, France, 75015
    • AP-HP Hopital Europeen Georges Pompidou
  • Rennes, France, 35000
    • CHU Rennes - Hôpital Pontchaillou
  • Toulouse, France, 31059 Cedex 9
    • CHU de Toulouse - Hôpital Larrey
  • Tours, France, 37000
    • CHRU de Tours - Hôpital Bretonneau
• Italy
  • Modena, Italy, 41124
    • Azienda Ospedaliero-Universitaria di Modena
  • Naples, Italy, 80131
    • AORN - Ospedali dei Colli - Ospedale V. Monaldi
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas - Pneumologia 1
  • PD
    • Padova, PD, Italy, 35128
      • Azienda Ospedale - Università Padova
  • RM
    • Roma, RM, Italy, 00168
      • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
  • SI
    • Siena, SI, Italy, 53100
      • Azienda Ospedaliero Universitaria Senese
  • TS
    • Trieste, TS, Italy, 34149
      • Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
• Netherlands
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Erasmus MC
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • St. Antonius Ziekenhuis - Locatie Nieuwegein
• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Lørenskog, Norway, 1478
    • Akershus University Hospital
  • Oslo, Norway, 0372
    • Oslo University Hospital, Rikshospitalet
• Romania
  • Bucharest, Romania, 050159
    • Institutul de Pneumoftiziologie Marius Nasta
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400371
      • Spitalul Clinic de Pneumoftiziologie ''Leon Daniello''
  • Dolj
    • Craiova, Dolj, Romania, 200515
      • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie ''Victor Babes'' Craiova
  • Timiș County
    • Timișoara, Timiș County, Romania, 300310
      • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie dr. Victor Babes Timisoara
• South Korea
  • Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16499
      • Ajou University Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico Universitario de Santiago
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06010
    • University of Health Sciences Gulhane Faculty of Medicine
  • Bursa, Turkey (Türkiye), 16059
    • Uludag University Medical Faculty
  • Izmir, Turkey (Türkiye), 35100
    • Ege University Medical Faculty Hospital
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Birmingham, United Kingdom, B15 2GW
    • Queen Elizabeth Hospital Birmingham
  • Edinburgh, United Kingdom, EH16 4SA
    • NHS Lothian, Edinburgh Royal Infirmary
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust
  • London, United Kingdom, SW3 6HP
    • Royal Brompton Hospital
  • Manchester, United Kingdom, M23 9QZ
    • Manchester University NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS Foundation Trust
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine at USC
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Miami, Florida, United States, 33144
      • Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Pulmonix, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Intravenous infusions of placebo every 4 weeks over 24 weeks
Experimental: CAL101	Drug: CAL101; Intravenous infusions of CAL101 every 4 weeks over 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in forced vital capacity (FVC) compared to placebo	28 weeks

Collaborators and Investigators

• Sponsor: Calluna Pharma AS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; idelalisib
• Other Study ID Numbers: CAL101-201; 2024-518339-12-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No