The AIRTIVITY TM Study: A study to find out whether BI 1291583 helps people with bronchiectasis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

21 Aug 2025 → ongoing

Decision date (initial)

2025-08-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-518589-29-00

WHO UTN

U1111-1317-2315

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety

To demonstrate superiority of BI 1291583 compared to placebo on the primary endpoint, the annualised rate of adjudicated pulmonary exacerbations in participants with bronchiectasis

Secondary objectives 2

1. The main secondary objective is to demonstrate a risk reduction in adjudicated pulmonary exacerbations, an improvement in the respiratory symptoms as measured by the absolute change from baseline in QOL-B respiratory symptoms score (in participants ≥16 years), a reduction in lung function decline as measured by the change from baseline in FEV1 %pred and FVC %pred and a reduction in the annualised rate of severe adjudicated pulmonary exacerbations for BI 1291583 when compared to placebo.
2. An additional secondary objective of the trial is to show an effect of BI 1291583 on risk reduction of severe adjudicated pulmonary exacerbations compared to placebo.

Conditions and MedDRA coding

Bronchiectasis

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency, Food And Drug Administration, Center For Drug Evaluation, European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003451-PIP01-23

Plan to share IPD

Yes

IPD plan description

Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female participants. WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information.
2. Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
3. Age of participants when signing the informed consent/assent ≥12 years. a. Adolescents need to weigh at least 35 kg at Visit 1.
4. Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist. Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.
5. Adult participants should be able to produce sputum for P. aeruginosa assessment during the screening period.
6. History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either: a. at least 2 exacerbations, or b. at least 1 exacerbation and an SGRQ Symptoms score of >40 at screening Visit 1 (adults only) c. at least 1 exacerbation and high symptom burden according to the investigator’s judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on CFTR-MT, at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.

Exclusion criteria 12

1. Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
2. Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
3. Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
4. Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
5. Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
6. Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
7. Major surgery (major according to the investigator’s assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
8. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
9. Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
10. eGFR according to CKD-EPI formula (adults) or CKiD-U25 (adolescents) <30 mL/min at Visit 1.
11. Previous treatment with a DPP1 (CatC) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed).
12. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76.

Secondary endpoints 6

1. Absolute change from baseline in post-bronchodilator FEV1 %pred at Week 52
2. Absolute change from baseline in QOL-B respiratory symptoms domain score at Week 52 (participants ≥16 years)
3. Time to first adjudicated pulmonary exacerbation up to Week 76
4. Absolute change from baseline in post-bronchodilator FVC %pred at Week 52
5. Annualised rate of severe adjudicated pulmonary exacerbations up to Week 76
6. Time to first severe adjudicated pulmonary exacerbation up to Week 76

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Third parties 2

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

22 EU/EEA countries · 176 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 473 files

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

Application history

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