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A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis

NCT07719023 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2026-07-22

No results posted yet for this study

Summary

This is a phase 3 clinical study conducted in China. The primary objective is to compare the efficacy and safety of AK3280 400 mg versus placebo and active control (pirfenidone) in IPF patients.

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Interventions

DRUG

AK3280

Participants will receive AK3280 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.

DRUG

Placebo

Participants will receive placebo matching 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.

DRUG

Pirfenidone

Participants will receive pirfenidone three times daily, within 30 minutes after meals. Initial dosing should be titrated gradually under doctor guidance: start with 200 mg each time, increase by 200 mg each time to maintain final dose of 600 mg each time within 2 weeks.

Sponsors & Collaborators

  • Shanghai Ark Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhen Fu, Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-09-30
Completion
2029-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07719023 on ClinicalTrials.gov