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

NCT05424887 | Unknown Phase 2

• 1 other identifier: AK3280-2002
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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

  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

  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

  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

  Main study: Up to 24 weeks; Extended study: Up to 48 weeks

Study Arms (4)

100 mg AK3280

EXPERIMENTAL

After the 4-week screening period, Eligible subjects will be administered daily 100 mg AK3280 b.i.d. for 24weeks

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

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.

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.

Drug: AK3280

Interventions

AK3280 DRUG

Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral

100 mg AK3280; 200 mg AK3280; Extension Study Cohort

Placebo DRUG

Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients who sign the informed consent form before participating in the study.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Patients with %FVC between 50% and 90% (inclusive) at screening, and hemoglobin-corrected %DLco between 30% and 90% (inclusive).
• \. 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.
• \. Patients whose 6MWT distance is ≥100 m without auxiliary support.

You may not qualify if:

• \. Patients suffering from interstitial pneumonia of other known causes.
• \. Patients who plan to undergo lung transplantation within 6 months after screening.
• \. Patients suffering from other clinically significant lung diseases (such as asthma, chronic obstructive pulmonary disease, etc.) in addition to IPF.
• \. 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.
• \. 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.
• \. Patients with forced expiratory volume in the first second (FEV1)/FVC ratio \<0.7 after the use of bronchodilators at screening.
• \. 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.
• \. Patients with peripheral capillary blood oxygen saturation (SpO2) at rest \<88%.
• \. Patients suffering from any clinically diagnosed connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis.
• \. Patients with New York Heart Association (NYHA) heart function classification of Class III-IV.
• \. 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.
• \. Patients with diabetes that is not stably controlled at the time of screening (glycated hemoglobin \[HbA1c\]\> 10%).
• \. Patients hospitalized due to acute exacerbation of IPF within 4 weeks before screening or during the screening period.
• \. 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).
• \. 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

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Jihong Liu

  Medical Director

  STUDY DIRECTOR

• Yan Wu

  Chief Medical Officer

  STUDY CHAIR

Central Study Contacts

Chao Yu

CONTACT

86-15718873093; chao.yu@arkbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: June 21, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)