Idiopathic Pulmonary Fibrosis (IPF)Phase 3NCT07719023
A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 3 study testing AK3280 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis (IPF), run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- AK3280 and Pirfenidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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)
- History of immunodeficiency, including but not limited to HIV infection
- 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
- Use of prohibited medications with potential effects on efficacy endpoints within 4 weeks or 5 half-lives (whichever is longer) prior to randomization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Huaping Dai, +861084205566, daihuaping@ccmu.edu.cn
Huaping Dai
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- AK3280, Placebo, Pirfenidone
- Keywords
- AK3280, IPF, Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK3280Drug
Participants will receive AK3280 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.
PlaceboDrug
Participants will receive placebo matching 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart.
PirfenidoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| AK3280 400 mg BID | Experimental | During the randomized controlled treatment study, participants will receive AK3280 400 mg twice daily in a masked manner. Receives: Drug: AK3280 |
| Placebo | Placebo comparator | During the randomized controlled treatment study, participants will receive placebo matching 400 mg twice daily in a masked manner. Receives: 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. Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 52
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 12, 24, 42, and 52
Change from baseline in 6MWT distance at Week 12, 24, 42, and 52
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhen Fu, Medical Director, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719023
- Sponsor's protocol ID
- AK3280-2005
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07719023
- Acronym / sponsor ID
- AK3280-2005
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- AK3280, IPF, Pirfenidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 263 participants (estimated)
- Lead sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AK3280 400 mg BID | Experimental | Drug: AK3280During the randomized controlled treatment study, participants will receive AK3280 400 mg twice daily in a masked manner. |
| Placebo | Placebo comparator | Drug: PlaceboDuring the randomized controlled treatment study, participants will receive placebo matching 400 mg twice daily in a masked manner. |
| Pirfenidone 600 mg TID | Active comparator | Drug: PirfenidoneDuring the randomized controlled treatment study, participants will receive pirfenidone titrated gradually to 600 mg three times daily in an open-label manner. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK3280Participants will receive AK3280 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart. | Drug | AK3280 400 mg BID |
| PlaceboParticipants will receive placebo matching 400 mg twice daily, within 30 minutes after breakfast and dinner, with breakfast and dinner approximately 12 hours apart. | Drug | Placebo |
| PirfenidoneParticipants 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. | Drug | Pirfenidone 600 mg TID |
Primary outcome
Absolute change from baseline in FVC at Week 52
Time frame: Baseline to Week 52
The FVC indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
10 secondary outcomes
Absolute change from baseline in FVC at Week 12, 24, and 42
Time frame: 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
Time frame: At Week 12, 24, 42, and 52
Absolute change from baseline in standardized %pFVC at Week12, 24, 42, and 52
Time frame: 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
Time frame: At Week 12, 24, 42, and 52
Absolute change from baseline in hemoglobin-corrected %pDLco at Week 12, 24, 42, and 52
Time frame: At Week 12, 24, 42, and 52
Change from baseline in L-PF score at Week 12, 24, 42, and 52
Time frame: At Week 12, 24, 42, and 52
Change from baseline in 6MWT distance at Week 12, 24, 42, and 52
Time frame: At Week 12, 24, 42, and 52
Time to first acute exacerbation of IPF within 52 weeks
Time frame: Baseline to Week 52
Progression-free survival (PFS), defined as the time from randomization to disease progression or death, whichever occurs first.
Time frame: Baseline to Week 52
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 52 weeks
Time frame: Baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhen Fu, Medical Director study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK3280 and Pirfenidone in people with Idiopathic Pulmonary Fibrosis (IPF), run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayson Zhou (+8618796252099, jayson.zhou@arkbiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in FVC at Week 52 (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.