Clairleaf TM: A study to test long-term treatment with BI 1291583 in people with bronchiectasis who took part in a previous study with this medicine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

5 Sep 2023 → ongoing

Decision date (initial)

2023-08-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-503290-38-00

WHO UTN

U1111-1292-0921

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective is to evaluate safety by assessing the absolute number and the percent of patients with treatment-emergent adverse event (TEAEs) over the course of the trial.

Secondary objectives 2

1. Assess the impact of BI 1291583 in prolonging the time to first pulmonary exacerbation.
2. Assess the impact of BI 1291583 in reducing the rate of pulmonary exacerbation events.

Conditions and MedDRA coding

Bronchiectasis

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients who completed treatment period in Phase II trial (1397-0012 or 1397-0013) as planned per protocol.
2. Male or female patients. Women of childbearing potential (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 patient information.
3. Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion criteria 13

1. Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or AST and/or ALT >3.0x ULN at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then).
2. Estimated glomerular filtration rate (eGFR) according to CKD-EPI formula <30 mL/min at Visit 1. (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then).
3. An absolute blood neutrophil count <1,000/mm3 (equivalent to <1,000 cells/μL or <109 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then).
4. Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the lab tests, if no more than 6 weeks passed since then)., that in the opinion of the investigator may put the patient at risk by participating in the trial.
5. A new diagnosis of: • Hypogammaglobulinemia • Common variable immunodeficiency • α1-antitrypsin deficiency being treated augmentation therapy • Allergic bronchopulmonary aspergillosis being treated or requiring treatment • Tuberculosis or non-tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines • Palmoplantar keratosis; or keratoderma climactericum • Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial • Psoriasis affecting palms and soles; or body surface area for psoriasis ≥10% • Reactive arthritis (Reiter’s syndrome); keratoderma blennorrhagicum • Pityriasis rubra pilaris • Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis ≥10% • Active extensive verruca vulgaris, as per investigator’s discretion • Active fungal infection of hand and/or feet not adequately treated and responsive to antifungal therapy, as per investigator’s discretion
6. Any clinically relevant respiratory infection within 4 weeks prior Visit 2 - unless recovered in the opinion of the investigator by Visit 2
7. Any acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2
8. Positive serological tests for hepatitis B, hepatitis C (also confirmed with HCV RNA), or human immunodeficiency virus (HIV) infection, or known infection status at Visit 2.
9. Any new evidence of a concomitant disease, such as PLS, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the trial.
10. Received any live attenuated vaccine within 4 weeks prior to Visit 1.
11. Medical conditions associated with severe periodontal disease (to be evaluated by a periodontist or dentist) at Visit 1: • Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before Visit 2 (e.g. pulp necrosis) • Severe periodontal disease defined as with pocket depth measurements ≥6 mm on 2 or more teeth • Class-3 mobility or Class-3 furcation involvement
12. Patients who must or wish to continue the intake of restricted medications (Table 6) or any drug considered likely to interfere with the safe conduct of the trial.
13. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occurrence of treatment-emergent AEs (TEAEs) over the course of this trial

Secondary endpoints 2

1. Time to first pulmonary exacerbation from first drug administration in this trial to the end of the trial
2. Rate of pulmonary exacerbations (number of events per person-time) over the course of this trial

Investigational products

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

Test 3

Placebo 3

Auxiliary 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 1

Boehringer Ingelheim RCV GmbH & Co. KG

Sponsor organisation

Boehringer Ingelheim RCV GmbH & Co. KG

Address

Dr.-Boehringer-Gasse 5-11, Meidling Meidling

City

Vienna

Postcode

1120

Country

Austria

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50

City

Sant Cugat Del Valles

Postcode

08174

Country

Spain

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

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

14 EU/EEA countries · 61 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 260 files

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

Application history

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