Senicapoc in patients with progressive fibrotic interstitial lung disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Lillebaelt Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

10 Aug 2025 → ongoing

Decision date (initial)

2024-08-30

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Novo Nordisk Foundation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To evaluate the safety and efficacy of Senicapoc in addition to local standard of care compared to placebo in subjects with Progressive Fibrotic Interstitial Lung Disease, evaluated by the rate of decline of forced vital capacity (FVC) in mL of predicted over a period of 26 weeks

Secondary objectives 12

1. To evaluate the efficacy of Senicapoc on disease progression −Disease progression defined as the composite endpoint of ≥5% absolute decline in percent predicted forced vital capacity (%FVC) or all-cause mortality at 26 weeks.
2. Time to first respiratory-related hospitalization until the end of the study.
3. Time to first all-cause non-elective hospitalization until the end of the study.
4. Time to respiratory-related mortality until the end of the study.
5. Time to lung transplant until the end of the study
6. Time to first acute exacerbation (as evaluated by the investigator) until the end of the study.
7. Time to all-cause mortality or respiratory-related hospitalizations until the end of the study.
8. Change from baseline in the VAS of dyspnea total score at 26 weeks.
9. Changes from baseline in quality of life
10. Safety and tolerability of senicapoc over time until the end of the study.
11. ICA-17043 levels in plasma in the group receiving active treatment.
12. Registration of adverse events.

Conditions and MedDRA coding

Progressive Fibrotic Interstitial Lung Disease

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. A diagnosis of F-ILD as per applicable ATS/ERS/JRS/ALAT guideline at the time of diagnosis
2. Able and willing to comply with the protocol requirements and signed the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
3. Male or female subject aged ≥18 years on the day of signing the ICF
4. Chest HRCT historically performed within 24 months prior to inclusion
5. FVC > 45 %, FEV1/FVC >0,7 or > LLN
6. An annual FVC decline of at least 5%, based on at least three FVC measurements within 6–24 months before enrolment

Exclusion criteria 11

1. History of malignancy within the past 5 years
2. A current immunosuppressive condition
3. Diagnosed with Sickle cell disease
4. Abnormal renal function defined as estimated creatinine clearance, adjusted to body surface area <30 mL/min.
5. Current alcohol or substance abuse
6. Moderate to severe hepatic impairment (Child-Pugh B or C); and/or abnormal LFT at screening, defined as AST, and/or ALT, and/or total bilirubin ≥1.5xULN, and/or GGT ≥3xULN
7. Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period
8. Diagnosis of severe pulmonary hypertension
9. History of lung volume reduction surgery or lung transplant.
10. Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
11. Clinically significant abnormalities detected on ECG of either rhythm or conduction, a QTcF >450 ms, or a known long QT syndrome.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of decline of FVC (in mL) over a period of 26 weeks

Secondary endpoints 9

1. Absolute decline in percent predicted forced vital capacity (%FVC) over 13 and 26 weeks
2. All-cause mortality.
3. Chance in Vas of dyspnea
4. All-cause non-elective hospitalizations
5. Respiratory-related mortality
6. Acute exacerbations (as evaluated by the investigator)
7. Changes in quality of life, assessed by the EQ-5D
8. Amount and type of adverse events.
9. Changes in quality of life, assessed by the SGRQ-I and K-BILD total score. (Danish and UK sites only)

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Lillebaelt Hospital

Sponsor organisation

Lillebaelt Hospital

Address

Beriderbakken 4

City

Vejle

Postcode

7100

Country

Denmark

Scientific contact point

Organisation

Lillebaelt Hospital

Contact name

Line Kølner-Augustson

Public contact point

Organisation

Lillebaelt Hospital

Contact name

Line Kølner-Augustson

Third parties 3

Locations

2 EU/EEA countries · 4 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 8 files

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

Application history

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