Anlotinib Capsules in the Treatment for IPF/PF-ILDs

June 3, 2026 updated by: Xiaoying Huang, First Affiliated Hospital of Wenzhou Medical University

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anlotinib Capsules for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)/Progressive Fibrosis-interstitial Lung Disease (PF-ILDs)

This is an exploratory Phase 2 study evaluating the use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with forced vital capacity (FVC) as the primary efficacy endpoint.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Drug: Anlotinib The dose of anlotinib hydrochloride is 8 mg per dose, taken orally once daily before breakfast. The treatment schedule is 2 consecutive weeks of dosing followed by a 1-week break.

The primary endpoint of this study is the change from baseline in forced vital capacity (FVC) at Week 24. Blinded treatment continues through Week 52 to evaluate longer-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs, including the change from baseline in FVC at Week 52 as a secondary/supportive endpoint. After Week 52, all subjects may enter an extension period if they wish. If a dose is missed and the next scheduled dose is due within 12 hours, the missed dose should not be taken.

Drug: Placebo Placebo is taken orally once daily before breakfast, following the same schedule: 2 consecutive weeks of dosing followed by a 1-week break.

Consistent with the study design, the primary endpoint is the change from baseline in FVC at Week 24. Blinded placebo administration continues through Week 52 to support the evaluation of longer-term efficacy and safety, with the change from baseline in FVC at Week 52 as a secondary/supportive endpoint. After Week 52, all subjects may enter an extension period if they wish. If a dose is missed and the next scheduled dose is due within 12 hours, the missed dose should not be taken.

FVC stands for forced vital capacity, which is the maximum amount of air that can be forcefully exhaled after a deep inspiration, performed as quickly and completely as possible. This measure assesses lung function and is the core endpoint for evaluating treatment effects in this study.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The participants voluntarily joined the study and signed an informed consent form. They showed good compliance throughout the study.
  2. The study includes individuals aged 40-85 years old, of any gender, with an expected lifespan of over 1 year.
  3. Subjects who meet either of the following two criteria: a. HRCT results confirming IPF diagnosis within the past 5 years and HRCT results within the past 12 months showing a range of parenchymal fibrotic changes between ≥10% and <50%, with less than 25% honeycombing change in the lung, and no other facilitating factors (e.g. asbestos exposure, allergic pneumonia, systemic sclerosis, rheumatoid arthritis) as detailed in Annex 1A. b. PF-ILDs: Patients with characteristics of fibrotic lung disease (see Annex 1B), and at least one of the following diagnostic criteria is met: i. Relative decline in FVC% predicted by ≥10% within 6 months; ii. Relative decline in FVC% predicted by ≥5-10% with worsening respiratory symptoms, or an increase in the degree of fibrosis on chest HRCT; ii. Worsening respiratory symptoms combined with an increase in the degree of fibrosis on chest HRCT;
  4. Carbon monoxide diffusion capacity (DLco) (corrected for hemoglobin) between 30% and 80% of predicted value;
  5. Forced vital capacity (FVC) ≥ 45% predicted;
  6. The 6MWT distance is ≥ 150 meters
  7. Arterial partial pressure of oxygen (PaO2) ≥ 60 mmHg (measured at sea level atmospheric pressure, at rest, and breathing room air)

  8. "Major organ functions are good, and meet the following criteria: a. Standard blood routine examination (not corrected by blood transfusion or hematopoietic growth factor drugs in the past 7 days): hemoglobin (HGB) ≥ 90 g/L; absolute neutrophil count (NEUT) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; b. Biochemical examination should meet the following criteria: total bilirubin (TBL) ≤ 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate (Ccr) ≥ 60 ml/min; c. Coagulation function or thyroid function examination should meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5 × ULN (not receiving anticoagulation therapy) or stable use of anticoagulants in the 2 weeks before enrollment; d. Thyroid-stimulating hormone (TSH) ≤ ULN after standard treatment; if abnormal, T3 and T4 levels should be investigated and can be enrolled if T3 and T4 levels are normal.

    e. Echocardiography evaluation: Left ventricular ejection fraction (LVEF) ≥50%

  9. Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study.

Exclusion Criteria:

  1. Patients with acute exacerbation of IPF/PF-ILDs.;
  2. Multiple factors that affect oral medication (such as dysphagia, chronic diarrhea, and intestinal obstruction)
  3. Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the study treatment.
  4. Long-standing non-healing wound or fracture.
  5. Patients who have experienced thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism, within the past 6 months, or those with other bleeding tendencies.

  6. Subjects with any severe or uncontrolled comorbidities or undergoing immunotherapy, such as:

    1. Blood pressure remains uncontrolled even after antihypertensive therapy (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); 2nd-degree myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥450ms (men), QTc ≥470ms (women)) or 2nd-degree congestive heart failure (New York Heart Association (NYHA) classification); pulmonary or systemic infections within 4 weeks before enrollment;
    2. Severe pulmonary arterial hypertension (systolic pulmonary artery pressure (SPAP) ≥70mmHg);
    3. Renal failure requiring hemodialysis or peritoneal dialysis;
    4. History of immune deficiency diseases, including HIV-positive or other acquired or congenital immune deficiency diseases, or history of organ transplantation;
    5. Known clinically significant liver disease history, including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (>2500 copies/mL or >500IU/mL, and greater than the upper limit of normal); known hepatitis C virus (HCV) infection and positive HCV RNA (>1×103 copies/mL), or other decompensated liver diseases;
    6. Fasting blood glucose (FBG) >10mmol/L after administration of hypoglycemic drugs (poor blood glucose control patients);
    7. Urine routine test indicates urine protein ≥+, and 24-hour urine protein quantitation is confirmed to be >1.0g.
  7. Received high-dose steroids (e.g. prednisone >15mg/kg) within 1 month prior to randomization；
  8. Use of immunosuppressants within 1 month prior to randomization after enrollment;
  9. Long-term use (>1 week) of drugs such as amiodarone that may cause pulmonary fibrosis prior to enrollment;
  10. Received interferon, N-acetylcysteine (>1800mg), or other anti-fibrotic drugs within 1 month prior to randomization
  11. Prior treatment with nintedanib or pirfenidone is allowed only if discontinued at least 28 days before randomization; patients with a washout period of less than 28 days are excluded.
  12. Participation in other drug trials within 3 months prior to randomization
  13. The researcher considers any ineligible candidates.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib
Experimental: The dosage of Anlotinib is 8mg per dose, once daily, to be taken orally before breakfast.
Drug: Anlotinib
Drug: Anlotinib The dose of anlotinib hydrochloride is 8mg per dose, taken orally once daily before breakfast. The drug is taken continuously for 2 weeks, followed by a 1-week break, until 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. If a dose is missed and the next scheduled dose is due within 12 hours, the missed dose should be skipped and not made up.
Placebo Comparator: Placebo,
control group：Placebo, take orally once daily before breakfast
Drug: Placebo
Matching placebo, taken orally once daily before breakfast, administered on the same 2-weeks-on/1-week-off schedule as the experimental arm. The placebo group serves as the comparator for evaluating the efficacy and safety of anlotinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in forced vital capacity (FVC) at Week 24, measured in mL
Time Frame: 24weeks
FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.
24weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in FVC at Week 52, measured in mL
Time Frame: 52weeks
FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.ients with IPF/PF-ILDs.
52weeks
Change from baseline in FVC % predicted at Weeks 24 and 52
Time Frame: 24weeks、52weeks
FVC (% predicted) was defined as forced vital capacity as a percentage of the predicted value.
24weeks、52weeks
Change from baseline in FEV1 at Weeks 24 and 52, measured in mL/s
Time Frame: 24weeks、52weeks
FEV1 (ml/s)was defined as forced expiratory volume in one second.
24weeks、52weeks
Change from baseline in FEV1 %predicted at Weeks 24 and 52
Time Frame: 24weeks、52weeks
FEV1 (% predicted)was forced expiratory volume in one second as a percentage of the predicted value .
24weeks、52weeks
Change from baseline in TLC at Weeks 24 and 52, measured in mL
Time Frame: 24weeks、52weeks
TLC(ml) was defined as Total Lung Capacity.
24weeks、52weeks
Change from baseline in TLC % predicted at Weeks 24 and 52
Time Frame: 24weeks、52weeks
TLC (% predicted) was defined as total lung capacity as a percentage of the predicted value.
24weeks、52weeks
Change from baseline in DLco%predicted at Weeks 24 and 52
Time Frame: 24weeks、52weeks
DLco%predicted was diffusing capacity of the lung for carbon monoxide as a percentage of the predicted value.
24weeks、52weeks
Change from baseline in 6-minute walk test at Weeks 24 and 52, measured in meters
Time Frame: 24weeks、52weeks
6-minute walk test is a commonly used method to evaluate physical function and cardiorespiratory health status. The walk distance, usually measured in feet or meters, is an important indicator of the test. It refers to the total distance covered by the subject within 6 minutes, which can reflect their endurance and exercise capacity.
24weeks、52weeks
Change from baseline in HRCT-based fibrosis score at Weeks 24 and 52, as assessed by a prespecified imaging review method.
Time Frame: 24weeks、52weeks
Relative change from baseline in HRCT.
24weeks、52weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Xiaoying Huang, Docter, the first affiliated hospital of wenhzou medical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ky2021-128-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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