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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Calluna Pharma AS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

8 Jul 2025 → ongoing

Decision date (initial)

2025-06-25

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

ORG-100052630

External identifiers

EU CT number

2024-518339-12-00

WHO UTN

U1111-1318-9678

ClinicalTrials.gov

NCT06736990

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To investigate the efficacy of CAL101 administered intravenously (IV) as evaluated by change from baseline in forced vital capacity (FVC) compared to placebo over 28 weeks for the treatment of patients with idiopathic pulmonary fibrosis (IPF)

Secondary objectives 2

1. To investigate the safety and tolerability of CAL101 compared to placebo in the treatment of patients with IPF
2. To investigate the effect of CAL101 on percent (%) predicted FVC compared to placebo. For additional secondary objectives pls refer to the Protocol

Conditions and MedDRA coding

Idiopathic Pulmonary Fibrosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. ≥ 40 years of age (at the time of informed consent).
2. 2. IPF diagnosis according to current international criteria.
3. 3. Definite or probably usual interstitial pneumonia (UIP) pattern on chest HRCT performed within 12 months of enrolment, confirmed by central review (if an evaluable HRCT < 12 months is not available, the baseline HRCT will be used to determine eligibility).
4. 4. Forced vital capacity (FVC) ≥ 45% of predicted (at Screening).
5. 5. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin ≥ 25% predicted.
6. 6. Forced expiratory volume in 1 second (FEV1)/FVC ≥ 0.70 or ≥ (predicted value minus 0.10) (if predicted value is <0.80) (at Screening)
7. 7. 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. Patients on antifibrotic should be anticipated to stay on the antifibrotic throughout the trial. For additional Inclusion Criteria pls refer to the Protocol

Exclusion criteria 5

1. 1. 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.
2. 2. Interstitial lung disease (ILD) other than IPF (including, but not limited to, connective tissue diseases, vasculitis).
3. 3. Acute IPF exacerbation within 16 weeks prior to screening and/or during the screening period (investigator-determined).
4. 4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to screening and/or during the screening period.
5. 5.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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute change from baseline in FVC (mL) through 28 weeks (repeated measures) confirmed by central read of FVC.

Secondary endpoints 2

1. Percentage of patients with adverse events (AEs) through 40 weeks.
2. Change from baseline in % predicted FVC through 28 weeks (repeated measures) confirmed by central reading of FVC. For additional secondary end points pls refer to the Protocol.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Calluna Pharma AS

Sponsor organisation

Calluna Pharma AS

Address

Gaustadalleen 21

City

Oslo

Postcode

0349

Country

Norway

Scientific contact point

Organisation

Calluna Pharma AS

Contact name

Calluna Pharma AS Regulatory

Public contact point

Organisation

Calluna Pharma AS

Contact name

Calluna Pharma AS Regulatory

Third parties 11

Locations

7 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 76 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications