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

Study Identifier
M25-268
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2024-518013-25-00
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Study Details

Medical Condition
  • Idiopathic Pulmonary Fibrosis
  • Study Drug
  • ABBV-142
  • Placebo for ABBV-142
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    40+ years

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Sec Clinical Research - East - Dothan - Graceland /ID# 278328
    Dothan, Alabama, United States, 36305
    Status
    Recruiting
    Location
    Christie Clinic on University /ID# 277871
    Champaign, Illinois, United States, 61820
    Status
    Recruiting
    Location
    Hannibal Regional Hospital /ID# 277984
    Hannibal, Missouri, United States, 63401
    Status
    Recruiting
    Location
    Centre d'Investigation Clinique Mauricie /ID# 277949
    Trois-Rivières, Quebec, Canada, G8T 7A1
    Status
    Recruiting
    Location
    Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029
    Kaohsiung City, Taiwan, 807
    Status
    Recruiting
    Location
    China Medical University Hospital /ID# 278039
    Taichung, Taiwan, 40447
    Status
    Recruiting