Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABBV-142, Placebo for ABBV-142.
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Fibrosis. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis
Overview
Idiopathic Pulmonary Fibrosis (IPF) is a rare, long-lasting lung disease that causes scarring of lung tissue, shortness of breath, and loss of lung function. IPF leads to significant loss of quality of life and shortened lifespan. This study is a platform study evaluating different types of treatments in patients with IPF. A platform study is a type of study that uses a single master protocol to evaluate different study treatments allowing for new study treatments or substudies to be added or closed over time. The main goals of the study are to evaluate the safety, tolerability (the degree to which the adverse symptoms can be handled by the patients during the study) and efficacy (how well study treatment works) of the study treatments, including ABBV-142 in Substudy 1 (SS1). ABBV-142 is an investigational drug being developed for the treatment of IPF. In SS1, participants will be randomly assigned to one of the 2 groups to receive either ABBV-142 or a matching placebo. This study is "double-blind", meaning that neither the participants nor the study doctors know who is given which study treatment. Approximately 165 adult participants with IPF will be enrolled in approximately 125 sites across the world. Participants will receive ABBV-142 or matching placebo for 52 weeks during the double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks in open-label treatment period. All participants will be followed for 120 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
- Drug ABBV-142
ABBV-142 - Drug Placebo for ABBV-142
Placebo for ABBV-142
Primary outcome measures
- Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL) [Time frame: Week 24]
- Percentage of Participants with Adverse Events (AE) [Time frame: Up to approximately 52 weeks]
Secondary outcome measures (10)
- Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL) [Time frame: Week 52]
- Relative Change From Baseline in FVC (mL) [Time frame: Week 24]
- Relative Change From Baseline in FVC (ml) [Time frame: Week 52]
- Absolute Change from Baseline in FVC% predicted [Time frame: Up to approximately 52 weeks]
- Relative Change From Baseline in FVC% predicted [Time frame: Up to approximately 52 weeks]
- Change From Baseline in Living with Pulmonary Fibrosis (L-PF) Overall Score [Time frame: Up to approximately 52 weeks]
- Time to First Absolute Decline From Baseline in FVC% Predicted of >= 10% [Time frame: Up to approximately 52 weeks]
- Time to First Relative Decline From Baseline in FVC% Predicted of >= 10% [Time frame: Up to approximately 52 weeks]
- Time to First Absolute Decline From Baseline in FVC% Predicted >= 5% [Time frame: Up to approximately 52 weeks]
- Time to First Relative Decline From Baseline in FVC% Predicted >= 5% [Time frame: Up to approximately 52 weeks]
Eligibility criteria
Inclusion criteria
\- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.
Exclusion criteria
- History of stroke within 6 months prior to screening
- In the opinion of the investigator, other clinically significant pulmonary abnormalities
- History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Sec Clinical Research - East - Dothan - Graceland /ID# 278328 — Dothan
- Christie Clinic on University /ID# 277871 — Champaign
- Hannibal Regional Hospital /ID# 277984 — Hannibal
Taiwan · 2 centers
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029 — Kaohsiung City
- China Medical University Hospital /ID# 278039 — Taichung
Canada · 1 center
- Centre d'Investigation Clinique Mauricie /ID# 277949 — Trois-Rivières
Identifiers
NCT: NCT07230288 · M25-268 · 2024-518013-25-00