Idiopathic Pulmonary FibrosisPhase 2AURORANCT06736990
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing CAL101 in people with Idiopathic Pulmonary Fibrosis, run by Calluna Pharma AS at 54 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- CAL101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 54 sitesin 11 countries
- Study dates
- 20 Jun 2025to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Trial locations and contacts
54 sites in 11 countries.
54 sites in 11 countries
United States9 sites
Cleveland Clinic
Cleveland, Ohio, 44195
National Jewish Health
Denver, Colorado, 80206
Pulmonix, LLC
Greensboro, North Carolina, 27403
University of Kansas Medical Center
Kansas City, Kansas, 66160
Keck School of Medicine at USC
Los Angeles, California, 90033
Y & L Advance Health Care, Inc. d/b/a Elite Clinical Research
Miami, Florida, 33144
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Utah Health
Salt Lake City, Utah, 84108
Southeastern Research Center
Winston-Salem, North Carolina, 27103
United Kingdom9 sites
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Birmingham Heartlands Hospital
Birmingham, B9 5SS
NHS Lothian, Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Royal Brompton Hospital
London, SW3 6HP
Manchester University NHS Foundation Trust
Manchester, M23 9QZ
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Italy7 sites
Azienda Ospedaliero-Universitaria di Modena
Modena, 41124
AORN - Ospedali dei Colli - Ospedale V. Monaldi
Naples, 80131
Azienda Ospedale - Università Padova
Padova, PD, 35128
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, RM, 00168
Istituto Clinico Humanitas - Pneumologia 1
Rozzano, 20089
Azienda Ospedaliero Universitaria Senese
Siena, SI, 53100
Azienda sanitaria universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
Trieste, TS, 34149
France5 sites
AP-HP Hopital Avicenne
Bobigny, 93000
AP-HP Hopital Europeen Georges Pompidou
Paris, 75015
CHU Rennes - Hopital Pontchaillou
Rennes, 35000
CHU de Toulouse - Hopital Larrey
Toulouse, 31059 Cedex 9
CHRU de Tours - Hôpital Bretonneau
Tours, 37000
South Korea5 sites
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Romania4 sites
Institutul de Pneumoftiziologie Marius Nasta
Bucharest, 050159
Spitalul Clinic de Pneumoftiziologie ''Leon Daniello''
Cluj-Napoca, Cluj, 400371
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie ''Victor Babes'' Craiova
Craiova, Dolj, 200515
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie dr. Victor Babes Timisoara
Timișoara, Timiș County, 300310
Spain4 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706
Denmark3 sites
Aarhus University Hospital
Aarhus, 8200
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
Norway3 sites
Haukeland University Hospital
Bergen, 5021
Akershus University Hospital
Lørenskog, 1478
Oslo University Hospital, Rikshospitalet
Oslo, 0372
Turkey (Türkiye)3 sites
University of Health Sciences Gulhane Faculty of Medicine
Ankara, 06010
Uludag University Medical Faculty
Bursa, 16059
Ege University Medical Faculty Hospital
Izmir, 35100
Netherlands2 sites
St. Antonius Ziekenhuis - Locatie Nieuwegein
Nieuwegein, Utrecht, 3435 CM
Erasmus MC
Rotterdam, South Holland, 3015 GD
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- CAL101, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAL101Drug
Intravenous infusions of CAL101 every 4 weeks over 24 weeks
PlaceboDrug
Intravenous infusions of placebo every 4 weeks over 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| CAL101 | Experimental | Not described Receives: Drug: CAL101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in forced vital capacity (FVC) compared to placebo
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start20 Jun 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calluna Pharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736990
- Sponsor's protocol ID
- CAL101-201
- Other IDs
- 2024-518339-12-00
- Acronym
- AURORA
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41124966
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of CAL101 in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06736990
- Acronym / sponsor ID
- AURORA / CAL101-201
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Calluna Pharma ASIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAL101 | Experimental | Drug: CAL101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAL101Intravenous infusions of CAL101 every 4 weeks over 24 weeks | Drug | CAL101 |
| PlaceboIntravenous infusions of placebo every 4 weeks over 24 weeks | Drug | Placebo |
Primary outcome
Change from baseline in forced vital capacity (FVC) compared to placebo
Time frame: 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 41124966Borchert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAL101 in people with Idiopathic Pulmonary Fibrosis, run by Calluna Pharma AS at 54 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, United Kingdom, Italy, France, South Korea and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in forced vital capacity (FVC) compared to placebo (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.