Anlotinib Capsules in the Treatment for IPF/PF-ILDs

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)

Anlotinib Capsules in the Treatment for IPF/PF-ILDs (NCT05828953) is a Phase 2 / Phase 3 interventional studying Interstitial Lung Diseases, sponsored by First Affiliated Hospital of Wenzhou Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with FVC as the primary efficacy endpoint to evaluate its effectivenes

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Interstitial Lung Diseases and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The participants voluntarily joined the study and signed an willing to sign a consent form 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. Force 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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. Force 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 (NR) ≤ 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 PF/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. Received treatment with nintedanib or pirfenidone for less than 28 days before randomization. 12. Participation in other drug trials within 3 months prior to randomization 13. The researcher considers any ineligible candidates.

Treatments Being Tested

DRUG

Anlotinib

Drug: Anlotinib The dose of nintedanib 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 dose is due within 12 hours, it should not be made up.

DRUG

Placebo

Placebo, taken orally once daily before breakfast. 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 dose is due within 12 hours, it should not be made up.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05828953), the sponsor (First Affiliated Hospital of Wenzhou Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05828953 clinical trial studying?

The use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with FVC as the primary efficacy endpoint to evaluate its effectivenes The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05828953?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05828953?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05828953. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05828953. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.