Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

NCT06714123 | Recruiting Phase 2

• 4 other identifiers: FibropocNNF21OC00718602024-511131-97-00IRAS 1009969
• Study Type: interventional
• Target: 140
• Locations: 3 countries
• Sites: 5

Brief Summary

This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease. Researchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening. Participants will be asked to take 3 tablets a day for 26 weeks. Within this period, doctors will follow the participants, ask for experience of adverse events, check lung function and organ status, and participants will need to fill out quality-of-life questionnaires. A total of 5 visits are required, at initiation, after4, 13, 26 and 52 weeks. The final visit will occur 52 weeks after initiation and consist of a normal visit in the outpatient clinic where the doctor asks for relevant information regarding the period after end of administration of the study drug.

Conditions

Pulmonary Fibrosis, Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Keywords

pulmonary fibrosis; Senicapoc; interstitial lung disease

Outcome Measures

Primary Outcomes (1)

• The rate of decline of forced vital capacity (FVC) in mL of predicted.

  Between baseline and 26 weeks

  26 weeks

Secondary Outcomes (5)

• The rate of decline of forced vital capacity (FVC) in % of predicted.

  26 weeks

• All cause mortality

  26 weeks

• Time to first respiratory-related hospitalization

  26 weeks

• Number and degree of adverse events after 26 weeks of treatment.

  26 weeks

• Change in the quality of life after 26 weeks of treatment

  26 weeks

Study Arms (2)

Senicapoc

ACTIVE COMPARATOR

Senicapoc 30 mg per day, administered as 3 tablets of 10 mg,.

Drug: Senicapoc

Placebo

PLACEBO COMPARATOR

Tablets similar in size, color and composition, as the active comparator, administered as 3 tablets a day.

Drug: Placebo

Interventions

Senicapoc DRUG

administering 30 mg senicapoc a day, in addition to standard of care.

Senicapoc

Placebo DRUG

Tablets similar in size and color

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Progressive fibrotic ILD or Progressive IPF diagnosed according to ATS/ERS/JRS/ALAT guidelines at the time of diagnosis
• Age \> 18 years
• HRCT historically performed within 24 months
• FVC \> 45 %, FEV1/FVC \> 0,7 or above LLN
• Annual FVC decline of at least 5% predicted, based on at least three FVC measurements within 6-24 months before enrolment
• Subject able to give informed consent.
• The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan
• Male subjects of reproductive potential agree to use highly effective contraception/preventive exposure measures from the time of first dose of IMP during the study, and until 90 days (male) after the last dose of IMP.
• Female subjects agree to use highly effective contraceptive during the study, and must show a negative pregnancy test before inclution.
• Able to walk at least 150 meters during the 6MWT at screening Visit 1;
• Able to read and complete the EQ-5D, SGRQ-I, K-BILD questionnaire.

You may not qualify if:

• Sickle cell disease
• Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator
• A current immunosuppressive condition
• Clinically significant abnormalities detected on ECG of either rhythm or conduction,
• Moderate to severe hepatic impairment (Child-Pugh B or C); and/or abnormal LFT at screening,
• Clinical laboratory test suggestive of cholestasis with total serum bile acid levels \> 3xULN.
• Abnormal renal function, defined as eGFT \> 30 ml/kg
• History of malignancy within the past 5 years
• Previous participation in a clinical study with IMP for fibrotic disease within the last 6 months.
• Concurrent participation in another interventional drug, device, or biological investigational research study, or use of an investigational agent within 5 half-lives of the agent
• Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and/or during the screening period.
• History of lung volume reduction surgery or lung transplant.
• Diagnosis of severe pulmonary hypertension
• Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period
• Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose \> 10 mg/day or equivalent.

Sponsors & Collaborators

• Vejle Hospital: lead
• Odense Patient Data Explorative Network: collaborator

Study Sites (5)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Kardiologisk Forskningsenhed 2161, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Tartu University Hospital,

Tartu, 50406, Estonia

RECRUITING

Division of Respiratory Sciences, Glenfield Hospital

Leicester, LE3 9QP, United Kingdom

NOT YET RECRUITING

University of East Anglia

Norwich, NR4 7TJ, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Interventions

senicapoc

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ole Hilberg, Proffesor

  Sygehus Lillebælt - Vejle

  STUDY DIRECTOR

Central Study Contacts

Line Kølner-Augustson, MD.

CONTACT

+45 28773005; line.augustson@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, International

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 3, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months after the publication of the results, all de-identified individual patient data will be made available for data sharing. There will be no predetermined end-date for the data sharing.
• Access Criteria: Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator.

Locations

ES (1); DK (2); GB (2)