Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. ≥ 40 years of age prior to screening

2. IPF diagnosis ≤ 7 years prior to screening

3. FVCpp ≥ 45%

4. Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30%
and < 90%

5. Current treatment for IPF with background therapy is allowed, if at a stable dose for
≥ 12 weeks prior to screening

6. If not currently receiving treatment for IPF (either treatment naïve or discontinued
prior treatment), participant must not have taken background therapy for at least 8
weeks prior to screening

Exclusion Criteria:

1. Receiving pharmacologic therapy for pulmonary hypertension

2. Self-reported smoking of any kind (not limited to tobacco)

3. History of malignancy within the past 5 years or ongoing malignancy other than basal
cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated
cervical carcinoma in situ

4. Hepatic impairment or end-stage liver disease

5. Renal impairment or end-stage kidney disease requiring dialysis

6. Pregnant or lactating female participant

7. Uncontrolled systemic arterial hypertension

8. Receiving any unapproved or investigational agent intended for treatment of fibrosis
in IPF

9. Prior administration of bexotegrast

10. Likely to have lung transplantation during the study (being on transplantation list is
not an exclusion)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/7/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Limper, M.D.

Contact us for the latest status

Contact information:

Samuel Nascak

(507) 422-3403

Nascak.Samuel@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Augustine Lee, M.D.

Contact us for the latest status

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available
.
CLS-20563308

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