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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT07230288
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-142 — DRUG
    ABBV-142
  • Placebo for ABBV-142 — DRUG
    Placebo for ABBV-142

Study Details

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.

Key Dates

First listed
Nov 17, 2025
Start date
Jan 23, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1: ABBV-142
    Participants will receive ABBV-142 for 52 week during double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks during open-label treatment period.
  • Placebo Comparator: Substudy 1: Placebo for ABBV-142
    Participants will receive placebo for ABBV-142 for 52 week during double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks during open-label treatment period.

Primary Outcome Measure

Absolute Change From Baseline in Forced Vital Capacity (FVC) (mL) [ Time Frame: Week 24 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
The University of Alabama at Birmingham /ID# 277613BirminghamAlabama35233-
Sec Clinical Research - East - Dothan - Graceland /ID# 278328DothanAlabama36305-
Clinical Research Specialists - Kissimmee /ID# 279184KissimmeeFlorida34746-
Christie Clinic on University /ID# 277871ChampaignIllinois61820-
University of Michigan Health System - Ann Arbor /ID# 279994Ann ArborMichigan48109-
Henry Ford Hospital /ID# 277843DetroitMichigan48202-
Hannibal Regional Hospital /ID# 277984HannibalMissouri63401-
Jefferson Health Honickman Center /ID# 279127PhiladelphiaPennsylvania19107-
Inova Fairfax Hospital /ID# 278469Falls ChurchVirginia22042-
Virginia Commonwealth University Medical Center /ID# 277992RichmondVirginia23219-

Find similar trials in Birmingham, AL

By research site
The University of Alabama at Birmingham· Birmingham, ALSec Clinical Research - East - Dothan - Graceland· Dothan, ALClinical Research Specialists - Kissimmee· Kissimmee, FLChristie Clinic on University· Champaign, ILUniversity of Michigan Health System - Ann Arbor· Ann Arbor, MIHenry Ford Hospital· Detroit, MI

Related Studies