Health TrialsbyHealthPanel

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

ConditionIdiopathic Pulmonary Fibrosis (IPF)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorShanghai Ark Biopharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

263 Participants
are divided into 3 treatment groups
Group A: AK3280 400 mg BIDExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Pirfenidone 600 mg TIDActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to Week 52

Secondary outcomes

1

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.

Time frame
Baseline to Week 12, 24, and 42
2

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.

Time frame
At Week 12, 24, 42, and 52
3

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.

Time frame
Baseline to Week 12, 24, 42, and 52
4

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.

Time frame
At Week 12, 24, 42, and 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Ark Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: