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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: AK3280; Drug: Placebo; Drug: Pirfenidone

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled and open-label active-controlled phase 3 clinical study conducted in China. This study plans to enroll 263 IPF participants. After completing screening assessments and meeting all enrollment criteria, IPF participants will be randomized in a 4:2:1 ratio to: AK3280 400 mg BID group (double-blind); Placebo BID group (double-blind); Pirfenidone 600 mg TID group (open-label).

The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and record any adverse medical events.

Participants are in the study for up to one and a half years. Subjects who complete the Week 52 visit of randomized controlled treatment study may be offered the opportunity to enter an open-label extension (OLE) study.

• Study Type: Interventional
• Enrollment (Estimated): 263
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jayson Zhou; Phone Number: +8618796252099; Email: jayson.zhou@arkbiosciences.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital
      • Contact: Huaping Dai; Phone Number: +861084205566; Email: daihuaping@ccmu.edu.cn
      • Principal Investigator: Huaping Dai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 40 years at enrolment
2. Diagnosis of IPF per ATS/ERS/JRS/ALAT 2022 guidelines
3. 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.
4. No prior anti-fibrotic treatment, or discontinued anti-fibrotic therapy for ≥4 weeks or 5 half-lives (whichever is longer) prior to randomization
5. Screening assessments meeting all of the following: 1) Standardized %pFVC ≥ 50% and ≤ 90%；2) Hemoglobin-corrected %pDLco ≥ 30% and ≤ 90%；3) Resting SpO2 ≥ 88%

Exclusion Criteria:

1. History of hypersensitivity to pirfenidone or AK3280
2. Known intolerance to pirfenidone single dose of 200 mg (total daily dose 600 mg)
3. Hospitalization due to acute IPF exacerbation within 8 weeks prior to screening or during screening
4. 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)
5. History of active tuberculosis within 12 months prior to screening
6. 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
7. 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
8. History of heart disease meeting NYHA Class III-IV
9. History of liver cirrhosis, severe hepatic impairment, or end-stage liver disease
10. 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
11. Screening cystatin C-estimated eGFR < 60 mL/min/1.73m²
12. Screening coagulation test meeting any of the following: 1) INR > 2; 2) Both PT and APTT prolonged > 1.5× ULN
13. History of any clinically diagnosed autoimmune disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
14. Uncontrolled diabetes during screening (HbA1c > 10%)
15. History of malignancy or possible malignancy upon evaluation (except treated localized basal cell carcinoma of the skin or cervical carcinoma in situ without recurrence)
16. History of immunodeficiency, including but not limited to HIV infection
17. History of any disease other than IPF with life expectancy < 18 months; or requiring long-term medical care, or limited self-care ability; or conditions that the investigator believes may affect participant's ability to complete this clinical study, complete study-related assessments, or affect safety or efficacy assessments
18. Use of prohibited medications with potential effects on efficacy endpoints within 4 weeks or 5 half-lives (whichever is longer) prior to randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK3280 400 mg BID; During the randomized controlled treatment study, participants will receive AK3280 400 mg twice daily in a masked manner.	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.
Placebo Comparator: Placebo; During the randomized controlled treatment study, participants will receive placebo matching 400 mg twice daily in a masked manner.	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.
Active Comparator: Pirfenidone 600 mg TID; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute change from baseline in FVC at Week 12, 24, and 42	The FVC indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.	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	Relative decline from baseline in FVC ≥10%, ≥15%, and ≥20% indicates varying degrees of disease progression.	At Week 12, 24, 42, and 52
Absolute change from baseline in standardized %pFVC at Week12, 24, 42, and 52	Standardized %pFVC is calculated as the ratio of measured FVC to predicted FVC. The predicted FVC is derived using a standardized formula.	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	Absolute decline from baseline in standardized %pFVC ≥10% indicates rapid disease progression.	At Week 12, 24, 42, and 52
Absolute change from baseline in hemoglobin-corrected %pDLco at Week 12, 24, 42, and 52	The hemoglobin-corrected %pDLco measures the ability of oxygen moves from alveoli to blood.	At Week 12, 24, 42, and 52
Change from baseline in L-PF score at Week 12, 24, 42, and 52	The L-PF is a self-administered, quality of life questionnaire validated for patients with progressive fibrosing interstitial lung disease (ILD), including IPF.	At Week 12, 24, 42, and 52
Change from baseline in 6MWT distance at Week 12, 24, 42, and 52		At Week 12, 24, 42, and 52
Time to first acute exacerbation of IPF within 52 weeks	An exacerbation of IPF is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality in HRCT.	Baseline to Week 52
Progression-free survival (PFS), defined as the time from randomization to disease progression or death, whichever occurs first.	IPF disease progression is defined as the occurrence of any of the following events: ≥ 10% absolute decline from baseline in standardized %pFVC; ≥ 15% absolute decline from baseline in hemoglobin-corrected %pDLco; Unscheduled hospitalization due to respiratory events	Baseline to Week 52
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 52 weeks	TEAEs and SAEs will be assessed via patient-reported symptoms, vital signs, physical examination, 12-lead ECG, HRCT, and laboratory assessments.	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
• Investigators: Study Director: Zhen Fu, Medical Director

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pirfenidone; IPF; AK3280
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; pirfenidone
• Other Study ID Numbers: AK3280-2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No