Idiopathic Pulmonary FibrosisPhase 2NCT05424887

A Study to Evaluate the Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 2 study testing AK3280 in people with Idiopathic Pulmonary Fibrosis, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: AK3280
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 1 siteChina
Study dates: Jul 2022to Oct 2024
Phase: Phase 2
Are there results?: None posted in the registry

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Patients who sign the informed consent form before participating in the study.
2. Patients who understand the importance of complying with the study medication regulations and completing all assessments on time during the entire study process, and agree to strictly abide by the protocol regulations, including the restrictions on concomitant medication during the study process.
3. Patients aged ≥40 years and ≤80 years at the time of enrollment. 4. Patients diagnosed with IPF within five years before screening (but at least 6 months before the first medication) who meet the standards of the latest American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2018 guidelines. The diagnosis of IPF needs to be reconfirmed during the screening assessment.
5. Patients who have completed the HRCT central review assessment during the screening period or completed the HRCT central assessment within 12 months before screening to confirm the diagnosis of IPF. If the patient is unable to provide pulmonary surgical biopsy pathology, the HRCT image must conform to usual interstitial pneumonia to confirm the diagnosis of IPF. Patients who have undergone pulmonary surgical biopsy as part of the initial diagnosis must submit their pathological slices for central review and assessment.
6. Patients who cannot tolerate pirfenidone or nintedanib and have received no more than 8 consecutive weeks of regular nintedanib or pirfenidone treatment, or patients who, the investigator considers, are not suitable to receive pirfenidone or nintedanib treatment, or patients who refuse to receive pirfenidone or nintedanib treatment.
7. Patients with %FVC between 50% and 90% (inclusive) at screening, and hemoglobin-corrected %DLco between 30% and 90% (inclusive).
8. Patients with relatively stable basic lung function, manifested by a <10% relative difference in FVC values at the screening day and the day before administration. The calculation formula is: (FVC value (L) at screening - FVC value (L) one day before administration) )/(FVC value (L) at screening )× 100% And patients who have no other clinically significant acute exacerbations of IPF determined by the investigators at the screening day and the day before administration.
9. Patients whose 6MWT distance is ≥100 m without auxiliary support.

Who cannot join

1. Patients suffering from interstitial pneumonia of other known causes.
2. Patients who plan to undergo lung transplantation within 6 months after screening.
3. Patients suffering from other clinically significant lung diseases (such as asthma, chronic obstructive pulmonary disease, etc.) in addition to IPF.
4. Patients suffering from any disease whose life expectancy is less than 12 months other than IPF; or patients requiring long-term medical care, or with limited self-care ability, or the investigator believes that it may affect the patient's participation in the completion of this clinical study, or completion of study-related examinations, or affect safety assessments or efficacy assessments.
5. Patients who have any evidence or clinically significant adverse physical conditions or abnormal examinations (physical examination, vital signs, ECG or laboratory test abnormalities, etc.) that the investigator believes may affect patient safety or the study endpoint assessments.
6. Patients with forced expiratory volume in the first second (FEV1)/FVC ratio <0.7 after the use of bronchodilators at screening.

Show all 38Show fewer

7. Patients with a positive bronchodilation test, manifested as a ≥ 12% increase in FEV1 and an absolute increase≥200 mL in FEV1 after the use of bronchodilators.
8. Patients with peripheral capillary blood oxygen saturation (SpO2) at rest <88%.
9. Patients suffering from any clinically diagnosed connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis.
10. Patients with New York Heart Association (NYHA) heart function classification of Class III-IV.
11. Renal insufficiency or a history of kidney injury; or creatinine clearance <60 mL/min, calculated using the Cockcroft-Gault formula; or patients with end-stage renal disease requiring dialysis.
12. Patients with diabetes that is not stably controlled at the time of screening (glycated hemoglobin [HbA1c]> 10%).
13. Patients hospitalized due to acute exacerbation of IPF within 4 weeks before screening or during the screening period.
14. Patients currently suffering from malignant tumors or who have been assessed to possibly have malignant tumors (except for localized basal cell carcinoma of the skin or cervical cancer in situ).
15. Local or systemic infection requiring: i. Hospitalization for ≥24 hours within 4 weeks before screening or during the screening period ii. Use of antibiotics (intravenous, intramuscular injection, oral or inhalation) within 4 weeks before screening or during the screening period
16. Acute phase of severe lung infection
17. Active tuberculosis requiring treatment within 12 months before screening
18. Patients with known immunodeficiency, including but not limited to HIV infection
19. Patients with acute or chronic hepatitis or patients with known liver cirrhosis
20. Any of the following circumstances: i. Aspartate aminotransferase (AST) ≥ 2 × upper limit of normal ii. Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal iii. Alkaline phosphatase (ALP) ≥ 2 × upper limit of normal iv. Total bilirubin ≥1.5 × upper limit of normal v. Severe liver damage or end-stage liver disease
21. Patients who have received any of the following chronic treatment within 4 weeks before randomization or within 5 half-lives (whichever is longer): i. Immunosuppressive or immunomodulatory therapy (such as azathioprine, cyclosporine A, cyclophosphamide, D-penicillamine, interferon, tumor necrosis factor-α antagonist) ii. Cytotoxic drugs (such as colchicine) iii. Pirfenidone iv. Tyrosine kinase inhibitors (such as nintedanib) v. Treatment of pulmonary hypertension (such as endothelin receptor antagonists, phosphodiesterase type-5 inhibitors, riociguat, prostacyclin or prostacyclin analogs) vi. N-acetylcystine vii. Other investigational drug viii. Any unapproved drugs for the treatment of IPF, such as interferon-γ, penicillamine, cyclosporine, and mycophenolate
22. Patients who have received standardized corticosteroid treatment (oral corticosteroids ≤ 10 mg/day are acceptable) within 4 weeks before screening or during the screening period or who require this treatment during the study period.
23. Patients who have used P-glycoprotein inhibitors or the substrates of transporters OAT1（Organic Anion Transporter 1）, OAT3（Organic Anion Transporter 3）, OCT2（organic cation transporter 2）, MATE2-K（multidrug and toxin extrusion 2-K）, and MATE1（multidrug and toxin extrusion 1）, with a time interval from the first treatment with the study drug less than five half-lives of the above drugs.
24. Patients with a history of drinking, drug or chemical abuse, which the investigator judges may harm or affect the patient's complete participation in this study.
25. Patients with known or suspected peptic ulcers, or patients with palsy, esophageal stenosis, or difficulty swallowing drugs.
26. Patients who smoked within 3 months before screening or are unwilling to quit smoking during the study period.
27. Patients whose 12-lead ECG results show QTcF（QT interval corrected using Fridericia's formula） interval > 450 msec in men and QTcF interval> 460 msec in women at screening; or patients with a family or personal history of QT interval prolongation syndrome.
28. Pregnant or breast-feeding women.
29. Women and men of childbearing age who are unwilling to use effective contraceptive methods during the study period or at least 3 months after the last administration of the investigational drug.
High-efficiency contraceptive methods for female patients include:
Complete abstinence
Female sterilization operation (bilateral oophorectomy with or without hysterectomy, total hysterectomy or tubal ligation) at least 6 weeks before receiving study treatment.
Male sterilization (at least 6 months before screening). For female patients in the study, the male partners who have undergone vasectomy should be their only partners.
Use of oral contraceptives (estrogen and progesterone), and female patients should have used the same contraceptives steadily for at least 3 months before receiving study treatment.
Injection or implantation of hormonal contraception or placement of intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception with similar efficacy (failure rate <1%), such as hormonal vaginal ring or transdermal hormonal contraception.
High-efficiency contraceptive methods for male patients include:
Vasectomy (a post-vasectomy record proves that there are no sperm in the ejaculation).
Having sex with a fertile female who uses the aforementioned high-efficiency contraceptive methods.

Trial locations and contacts

1 site in 1 country.

Chao Yu contact

86-15718873093

chao.yu@arkbiosciences.com

China1 site

China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Two Different Dose Groups of AK3280 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Compared to the Placebo Control Group

Read the detailed description

This study is a randomized, double-blind, placebo-controlled, multi-center phase II clinical study conducted in China to compare the efficacy and safety of two different dose groups of AK3280 in IPF patients compared to the placebo control group. One hundred and five IPF patients who have completed the screening assessment and meet the enrollment requirements will participate in this study and be randomized into 3 treatment groups in a 1:1:1 (35:35:35) ratio: AK3280 200 mg group, AK3280 100 mg group and placebo group; the frequency of medication for each treatment group is twice a day (BID).

This study is divided into a main study and an extension study. The main study includes a 4-week screening period, a 24-week medication observation period, and a 4-week safety follow-up period. The extension study includes a 24-week medication observation period and a 4-week safety follow-up period.

Conditions: Idiopathic Pulmonary Fibrosis
Being tested: AK3280, Placebo
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
Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
PlaceboDrug
Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

Study groups in NCT05424887
Study group	Role	What they receive
100 mg AK3280	Experimental	After the 4-week screening period, Eligible subjects will be administered daily 100 mg AK3280 b.i.d. for 24weeks Receives: Drug: AK3280
200 mg AK3280	Experimental	After the 4-week screening period, Eligible subjects will be administered daily 200 mg AK3280 b.i.d. for 24weeks Receives: Drug: AK3280
placebo	Placebo comparator	There are placebo controls in each dose cohort to assess the safety profile of the study medication. Subjects will be randomized to receive a placebo simultaneously as those subjects randomized to AK3280. Receives: Drug: Placebo
Extension Study Cohort	Experimental	The extension study includes a 24-week medication observation period and a 4-week safety follow-up period. Subjects who meet the requirements will enter the extension study after 24 weeks of treatment in the main study. Subjects entering the extension study will continue to orally take AK3280 200 mg for 24 weeks. Receives: Drug: AK3280

What is being measured

The primary outcome is the main question the study is designed to answer.

After 24 weeks of continuous medication, the absolute decrease in percentage of the predicted FVC from baseline in the AK3280 treatment group compared to the placebo control group.
Change in percentage of the predicted FVC from baseline
Measured: Up to 24 weeks

Secondary outcomes (27)

Assessment of whether AK3280 prolongs the progression-free survival of IPF subjects compared with the placebo control group within 24 weeks and 48 weeks of medication.
Progression-free survival is defined as the time from randomization to the first occurrence of any of the following events:
- The percentage of FVC to the normal expected value (%FVC) achieves an absolute decrease of 10%, or
- The percentage of DLco to the normal expected value (%DLco) achieves an absolute decrease of 15%, or
- Non-elective hospitalization due to respiratory events
- Death
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The changes from baseline in %DLco， in the AK3280 treatment group compared to the placebo control group
- After hemoglobin correction, the absolute decrease in %DLco
- DLco will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The proportion of subjects with a ≥15% absolute decrease in %DLco，in the AK3280 treatment group compared to the placebo control group
- After hemoglobin correction, the proportion of subjects with a ≥15% absolute decrease in %DLco
- DLco will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The absolute decrease in forced vital capacity (FVC) from baseline ， in the AK3280 treatment group compared to the placebo control group
FVC will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The proportion of patients with a percentage of decrease≥ 10%, ≥ 15% or ≥ 20% in FVC from baseline in each group
FVC will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The time to the percentage of decrease in FVC reaching 10% from baseline
FVC will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the changes from baseline in the 6MWT（six-minute walk test） distance in the AK3280 treatment group compared to the placebo control group
The 6MWT distance will be measured at 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks after the first administration on D1 respectively.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the acute exacerbation of IPF subjects - The time from randomization to the first acute exacerbation - The proportion of subjects who experience at least one acute exacerbation
A subject needs to meet all 3 criteria below to be judged to have acute exacerbation of IPF:
- Acute worsening or progression of dyspnea occurs within 1 month (manifested as rapid decline in lung function, worsening of hypoxemia, worsening of irritating dry cough, and worsening of wheezing after exercise, etc.)
- Chest HRCT（high-resolution computed tomography） shows new diffuse ground glass opacities (GGO) and/or consolidation opacities in both lungs on the background of the original mesh opacities, honeycomb opacities and other manifestations of usual interstitial pneumonia (UIP)
- Heart failure or fluid overload is ruled out
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the IPF-related mortality, all-cause mortality in IPF subjects
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The changes from baseline in the SGRQ（Saint George's Respiratory Questionnaire） total score in the AK3280 treatment group compared to the placebo control group
Saint George's Respiratory Questionnaire Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.
Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The proportion of subjects with changes from baseline in the SGRQ ≥4 points from baseline
Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the proportion of patients who have dose adjustments due to AEs in the AK3280 treatment group and the placebo control group
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the proportion of subjects who discontinue the medication due to adverse events (AE) in the AK3280 treatment group and the placebo control group
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Assessment of adverse events
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Assessment of serious adverse events (SAEs)
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal vital signs
Vital signs: include pulse, respiration, body temperature and blood pressure
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal Physical examination findings
Physical examination ： include height, weight, skin, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal 12-lead ECG readings
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal laboratory test results
Laboratory tests：include blood routine examination， blood biochemistry ，urine routine test
Measured: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Pharmacokinetic endpoint：The maximum plasma drug concentration (Cmax) of AK3280 and AK3280 M2
Measured: Day 1 and Day 7
Pharmacokinetic endpoint：Time to peak (Tmax) of AK3280 and AK3280 M2
Measured: Day 1 and Day 7
Pharmacokinetic endpoint：Area under the plasma drug concentration-time curve from 0 hour to 12 hours (AUC0-12h) of AK3280 and AK3280 M2
Measured: Day 1 and Day 7
Pharmacokinetic endpoint：Area under the plasma drug concentration-time curve extrapolated from 0 hour to infinity (AUC0-∞） of AK3280 and AK3280 M2
Measured: Day 1 and Day 7
Pharmacokinetic endpoint：Oral clearance (CL/F) of AK3280 and AK3280 M2
Measured: Day 1 and Day 7
Pharmacokinetic endpoint：Oral volume of distribution (Vd/F) of AK3280 and AK3280 M2
Measured: Day 1 and Day 7
Pharmacokinetic endpoint：Terminal half-life (t1/2) of AK3280 and AK3280 M2
Measured: Day 1 and Day 7
Pharmacokinetic endpoint：Accumulation coefficient of AK3280 and AK3280 M2
Measured: Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2022Oct 2024

First posted21 Jun 2022
Study startJul 2022 (estimated)
Primary completionJul 2024 (estimated)
Study completionOct 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Idiopathic Pulmonary FibrosisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 105 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05424887
Sponsor's protocol ID: AK3280-2002
Status last verified: Jul 2022
First submitted: 9 May 2022
Last updated: 20 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Chao Yu

86-15718873093

chao.yu@arkbiosciences.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Two Different Dose Groups of AK3280 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Compared to the Placebo Control Group
ClinicalTrials.gov ID: NCT05424887
Acronym / sponsor ID: AK3280-2002
Conditions: Idiopathic Pulmonary Fibrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 105 participants (estimated)
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2022 (estimated)
Primary completion: Jul 2024 (estimated)
Study completion: Oct 2024 (estimated)
First posted: 21 Jun 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
100 mg AK3280	Experimental	Drug: AK3280After the 4-week screening period, Eligible subjects will be administered daily 100 mg AK3280 b.i.d. for 24weeks
200 mg AK3280	Experimental	Drug: AK3280After the 4-week screening period, Eligible subjects will be administered daily 200 mg AK3280 b.i.d. for 24weeks
placebo	Placebo comparator	Drug: PlaceboThere are placebo controls in each dose cohort to assess the safety profile of the study medication. Subjects will be randomized to receive a placebo simultaneously as those subjects randomized to AK3280.
Extension Study Cohort	Experimental	Drug: AK3280The extension study includes a 24-week medication observation period and a 4-week safety follow-up period. Subjects who meet the requirements will enter the extension study after 24 weeks of treatment in the main study. Subjects entering the extension study will continue to orally take AK3280 200 mg for 24 weeks.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

1. Patients who sign the informed consent form before participating in the study.
2. Patients who understand the importance of complying with the study medication regulations and completing all assessments on time during the entire study process, and agree to strictly abide by the protocol regulations, including the restrictions on concomitant medication during the study process.
3. Patients aged ≥40 years and ≤80 years at the time of enrollment. 4. Patients diagnosed with IPF within five years before screening (but at least 6 months before the first medication) who meet the standards of the latest American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) 2018 guidelines. The diagnosis of IPF needs to be reconfirmed during the screening assessment.
5. Patients who have completed the HRCT central review assessment during the screening period or completed the HRCT central assessment within 12 months before screening to confirm the diagnosis of IPF. If the patient is unable to provide pulmonary surgical biopsy pathology, the HRCT image must conform to usual interstitial pneumonia to confirm the diagnosis of IPF. Patients who have undergone pulmonary surgical biopsy as part of the initial diagnosis must submit their pathological slices for central review and assessment.
6. Patients who cannot tolerate pirfenidone or nintedanib and have received no more than 8 consecutive weeks of regular nintedanib or pirfenidone treatment, or patients who, the investigator considers, are not suitable to receive pirfenidone or nintedanib treatment, or patients who refuse to receive pirfenidone or nintedanib treatment.

Key exclusion criteria (38 listed)

1. Patients suffering from interstitial pneumonia of other known causes.
2. Patients who plan to undergo lung transplantation within 6 months after screening.
3. Patients suffering from other clinically significant lung diseases (such as asthma, chronic obstructive pulmonary disease, etc.) in addition to IPF.
4. Patients suffering from any disease whose life expectancy is less than 12 months other than IPF; or patients requiring long-term medical care, or with limited self-care ability, or the investigator believes that it may affect the patient's participation in the completion of this clinical study, or completion of study-related examinations, or affect safety assessments or efficacy assessments.
5. Patients who have any evidence or clinically significant adverse physical conditions or abnormal examinations (physical examination, vital signs, ECG or laboratory test abnormalities, etc.) that the investigator believes may affect patient safety or the study endpoint assessments.

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
AK3280Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral	Drug	100 mg AK3280, 200 mg AK3280, Extension Study Cohort
PlaceboActive Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral	Drug	placebo

Primary outcome

After 24 weeks of continuous medication, the absolute decrease in percentage of the predicted FVC from baseline in the AK3280 treatment group compared to the placebo control group.
Time frame: Up to 24 weeks
Change in percentage of the predicted FVC from baseline

27 secondary outcomes

Assessment of whether AK3280 prolongs the progression-free survival of IPF subjects compared with the placebo control group within 24 weeks and 48 weeks of medication.
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The changes from baseline in %DLco， in the AK3280 treatment group compared to the placebo control group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The proportion of subjects with a ≥15% absolute decrease in %DLco，in the AK3280 treatment group compared to the placebo control group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The absolute decrease in forced vital capacity (FVC) from baseline ， in the AK3280 treatment group compared to the placebo control group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The proportion of patients with a percentage of decrease≥ 10%, ≥ 15% or ≥ 20% in FVC from baseline in each group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The time to the percentage of decrease in FVC reaching 10% from baseline
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the changes from baseline in the 6MWT（six-minute walk test） distance in the AK3280 treatment group compared to the placebo control group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the acute exacerbation of IPF subjects - The time from randomization to the first acute exacerbation - The proportion of subjects who experience at least one acute exacerbation
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the IPF-related mortality, all-cause mortality in IPF subjects
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The changes from baseline in the SGRQ（Saint George's Respiratory Questionnaire） total score in the AK3280 treatment group compared to the placebo control group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
The proportion of subjects with changes from baseline in the SGRQ ≥4 points from baseline
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the proportion of patients who have dose adjustments due to AEs in the AK3280 treatment group and the placebo control group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Within 24 and 48 weeks of medication, the proportion of subjects who discontinue the medication due to adverse events (AE) in the AK3280 treatment group and the placebo control group
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Assessment of adverse events
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Assessment of serious adverse events (SAEs)
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal vital signs
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal Physical examination findings
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal 12-lead ECG readings
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Number of participants with abnormal laboratory test results
Time frame: Main study: Up to 24 weeks; Extended study: Up to 48 weeks
Pharmacokinetic endpoint：The maximum plasma drug concentration (Cmax) of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7
Pharmacokinetic endpoint：Time to peak (Tmax) of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7
Pharmacokinetic endpoint：Area under the plasma drug concentration-time curve from 0 hour to 12 hours (AUC0-12h) of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7
Pharmacokinetic endpoint：Area under the plasma drug concentration-time curve extrapolated from 0 hour to infinity (AUC0-∞） of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7
Pharmacokinetic endpoint：Oral clearance (CL/F) of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7
Pharmacokinetic endpoint：Oral volume of distribution (Vd/F) of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7
Pharmacokinetic endpoint：Terminal half-life (t1/2) of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7
Pharmacokinetic endpoint：Accumulation coefficient of AK3280 and AK3280 M2
Time frame: Day 1 and Day 7

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Chao Yu contact

86-15718873093

chao.yu@arkbiosciences.com

Jihong Liu study director

Medical Director

Yan Wu study chair

Chief Medical Officer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK3280 in people with Idiopathic Pulmonary Fibrosis, 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 8 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chao Yu (86-15718873093, chao.yu@arkbiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

After 24 weeks of continuous medication, the absolute decrease in percentage of the predicted FVC from baseline in the AK3280 treatment group compared to the placebo control group. (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05424887.

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 20 Jul 2022.