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

NCT07719023 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: AK3280-2005
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

AK3280; IPF; Pirfenidone

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in FVC at Week 52

  The FVC indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.

  Baseline to Week 52

Secondary Outcomes (10)

• Absolute change from baseline in FVC at Week 12, 24, and 42

  Baseline to Week 12, 24, and 42

• Proportion of participants with relative decline from baseline in FVC ≥10%, ≥15%, and ≥20% at Week 12, 24, 42, and 52

  At Week 12, 24, 42, and 52

• Absolute change from baseline in standardized %pFVC at Week12, 24, 42, and 52

  Baseline to Week 12, 24, 42, and 52

• Proportion of participants with absolute decline from baseline in standardized %pFVC ≥10% at Week 12, 24, 42, and 52

  At Week 12, 24, 42, and 52

• Absolute change from baseline in hemoglobin-corrected %pDLco at Week 12, 24, 42, and 52

  At Week 12, 24, 42, and 52

Study Arms (3)

AK3280 400 mg BID

EXPERIMENTAL

During the randomized controlled treatment study, participants will receive AK3280 400 mg twice daily in a masked manner.

Drug: AK3280

Placebo

PLACEBO COMPARATOR

During the randomized controlled treatment study, participants will receive placebo matching 400 mg twice daily in a masked manner.

Drug: Placebo

Pirfenidone 600 mg TID

ACTIVE COMPARATOR

During the randomized controlled treatment study, participants will receive pirfenidone titrated gradually to 600 mg three times daily in an open-label manner.

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

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.

Pirfenidone 600 mg TID

AK3280 DRUG

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

AK3280 400 mg BID

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years at enrolment
• Diagnosis of IPF per ATS/ERS/JRS/ALAT 2022 guidelines
• HRCT central review completed during screening or within 12 months prior to screening. If participant did not undergo lung surgical biopsy, HRCT imaging must be consistent with usual interstitial pneumonia (UIP) pattern for definitive IPF diagnosis.
• No prior anti-fibrotic treatment, or discontinued anti-fibrotic therapy for ≥4 weeks or 5 half-lives (whichever is longer) prior to randomization
• Screening assessments meeting all of the following: 1) Standardized %pFVC ≥ 50% and ≤ 90%；2) Hemoglobin-corrected %pDLco ≥ 30% and ≤ 90%；3) Resting SpO2 ≥ 88%

You may not qualify if:

• History of hypersensitivity to pirfenidone or AK3280
• Known intolerance to pirfenidone single dose of 200 mg (total daily dose 600 mg)
• Hospitalization due to acute IPF exacerbation within 8 weeks prior to screening or during screening
• Within 4 weeks prior to screening or during screening, local or systemic infection requiring: 1) Hospitalization ≥ 24 hours; or 2) Use of systemic antibiotics (IV, IM, oral, or inhaled)
• History of active tuberculosis within 12 months prior to screening
• History of other clinically significant lung diseases besides IPF (e.g., asthma, COPD, interstitial pneumonia of known cause, acute severe pulmonary infection, etc.), or planned lung transplantation within 6 months after signing informed consent
• Post-bronchodilator FEV1/FVC \< 0.7 or positive bronchodilator response (defined as ≥ 12% relative increase in FEV1 and ≥ 200 mL absolute increase in FEV1 after bronchodilator use) during screening
• History of heart disease meeting NYHA Class III-IV
• History of liver cirrhosis, severe hepatic impairment, or end-stage liver disease
• Screening liver function abnormalities meeting any of the following:1) AST ≥ 2× ULN; 2) ALT ≥ 2× ULN; 3) ALP ≥ 2× ULN; 4) Total bilirubin ≥ 1.5× ULN
• Screening cystatin C-estimated eGFR \< 60 mL/min/1.73m²
• Screening coagulation test meeting any of the following: 1) INR \> 2; 2) Both PT and APTT prolonged \> 1.5× ULN
• History of any clinically diagnosed autoimmune disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
• Uncontrolled diabetes during screening (HbA1c \> 10%)
• History of malignancy or possible malignancy upon evaluation (except treated localized basal cell carcinoma of the skin or cervical carcinoma in situ without recurrence)

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhen Fu, Medical Director

  STUDY DIRECTOR

Central Study Contacts

Jayson Zhou

CONTACT

+8618796252099; jayson.zhou@arkbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the main study phase, participants, care Provider, and investigators are blinded to AK3280 versus placebo allocation but not to pirfenidone; pulmonary function assessors are blinded to all three groups. The extension study is an open-label phase.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

CN (1)