A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis

Sponsor
Haisco Pharmaceutical Group Co., Ltd.
Study ID
NCT07519070
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HSK44459 — DRUG
    HSK44459 Without IPF background therapy
  • HSK44459 — DRUG
    HSK44459 With Nintedanib
  • HSK44459 — DRUG
    HSK44459 With Pirfenidone
  • Placebo — DRUG
    Placebo Without IPF background therapy
  • Placebo — DRUG
    Placebo With Nintedanib
  • Placebo — DRUG
    Placebo With Pirfenidone

Study Details

This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).

Key Dates

Start date
Apr 5, 2026
Status verified
Mar 2026
Primary completion
Apr 5, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HSK44459
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in FVC from baseline at Week 52 [ Time Frame: Week 52 ]

Central Contacts

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