Study of Intravenous ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-03-12

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

AbbVie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the safety, tolerability, and efficacy of investigational products as monotherapy or in combinations in adult subjects with Idiopathic Pulmonary Fibrosis (IPF).

Conditions and MedDRA coding

Idiopathic Pulmonary Fibrosis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Paul-Ehrlich-Institut

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients aged ≥ 40 years.
2. History of IPF diagnosis within 7 years of screening visit.
3. Confirmed diagnosis of IPF: a. Diagnosis of IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest high-resolution Computed Tomography (HRCT) scan taken within 12 months of screening visit and, if available, (historical) surgical lung biopsy or transbronchical lung cryobiopsy, AND b. Usual Interstitial Pneumonia (UIP) or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to randomization visit. Patients with an "Indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a "UIP" or "Probable UIP" histopathology pattern. Subjects with an "Alternative diagnosis" HRCT finding are eligible if clinical diagnosis of IPF can be confirmed locally based on (historical) surgical lung biopsy or cryobiopsy demonstrating a "UIP" histopathology pattern.
4. Either stable treatment with antifibrotics for at least 8 weeks prior to screening visit or not treated with antifibrotics for at least 4 weeks prior to screening visit.
5. FVC ≥ 45% of predicted normal at screening visit.
6. Percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin (Hb) in a single breath ≥ 25% at screening visit.

Exclusion criteria 3

1. Relevant airways obstruction defined as pre-bronchodilator forced expiratory volume 1 second (FEV1)/FVC < 0.7 at screening visit.
2. Acute IPF exacerbation diagnosis within 4 months prior to screening and/or during the screening period (investigator determined).
3. Lower respiratory tract infection (e.g., infectious pneumonia, active tuberculosis) requiring antimicrobials within 4 weeks before screening visit and/or during the screening period.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute change from baseline in forced vital capacity (mL) at Week 24.

Secondary endpoints 7

1. Absolute change from baseline in FVC (mL) at Week 52.
2. Relative change from baseline in FVC (mL) at Week 24.
3. Relative change from baseline in FVC (mL) at Week 52.
4. Absolute and relative change from Baseline in FVC % predicted at Week 24.
5. Absolute and relative change from Baseline in FVC % predicted at Week 52.
6. Time to first ≥ 10% absolute decline in FVC% predicted.
7. Time to first ≥ 5% absolute decline in FVC% predicted.

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

ABBVIE CALLCENTER

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

ABBVIE CALLCENTER

Third parties 15

Locations

11 EU/EEA countries · 57 investigational sites

By country

Investigational sites

Results and documents

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

Documents 52 files

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

Application history

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