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Interstitial Lung DiseasesPhase 2NCT05828953

Anlotinib Capsules in the Treatment for IPF/PF-ILDs

A Phase 2 study testing Anlotinib in people with Interstitial Lung Diseases, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Interstitial Lung Diseases
What is being tested?
Anlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
28 Sep 2021to 30 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participants voluntarily joined the study and signed an informed consent form. They showed good compliance throughout the study.
  • The study includes individuals aged 40-85 years old, of any gender, with an expected lifespan of over 1 year.
  • 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;
  • Carbon monoxide diffusion capacity (DLco) (corrected for hemoglobin) between 30% and 80% of predicted value;
  • Forced vital capacity (FVC) ≥ 45% predicted;
  • The 6MWT distance is ≥ 150 meters
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  • Arterial partial pressure of oxygen (PaO2) ≥ 60 mmHg (measured at sea level atmospheric pressure, at rest, and breathing room air)
  • "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.
  • Echocardiography evaluation: Left ventricular ejection fraction (LVEF) ≥50%
  • 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.

Who cannot join

  • Patients with acute exacerbation of IPF/PF-ILDs.;
  • Multiple factors that affect oral medication (such as dysphagia, chronic diarrhea, and intestinal obstruction)
  • Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the study treatment.
  • Long-standing non-healing wound or fracture.
  • 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.
  • Subjects with any severe or uncontrolled comorbidities or undergoing immunotherapy, such as:
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  • 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;
  • Severe pulmonary arterial hypertension (systolic pulmonary artery pressure (SPAP) ≥70mmHg);
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • History of immune deficiency diseases, including HIV-positive or other acquired or congenital immune deficiency diseases, or history of organ transplantation;
  • 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;
  • Fasting blood glucose (FBG) >10mmol/L after administration of hypoglycemic drugs (poor blood glucose control patients);
  • Urine routine test indicates urine protein ≥+, and 24-hour urine protein quantitation is confirmed to be >1.0g.
  • Received high-dose steroids (e.g. prednisone >15mg/kg) within 1 month prior to randomization；
  • Use of immunosuppressants within 1 month prior to randomization after enrollment;
  • Long-term use (>1 week) of drugs such as amiodarone that may cause pulmonary fibrosis prior to enrollment;
  • Received interferon, N-acetylcysteine (>1800mg), or other anti-fibrotic drugs within 1 month prior to randomization
  • 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.
  • Participation in other drug trials within 3 months prior to randomization
  • The researcher considers any ineligible candidates.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Anlotinib, Placebo
Keywords
Idiopathic pulmonary fibrosis(IPF), Progressive fibrosis-interstitial lung disease(PF-ILDs), Anlotinib
Medical subject headings
Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnlotinibDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT05828953
Study groupRoleWhat they receive
AnlotinibExperimentalExperimental: The dosage of Anlotinib is 8mg per dose, once daily, to be taken orally before breakfast.
Receives: Drug: Anlotinib
Placebo,Placebo comparatorcontrol group：Placebo, take orally once daily before breakfast
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in forced vital capacity (FVC) at Week 24, measured in mL

    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.

    Measured: 24weeks

Secondary outcomes (9)

  1. Change from baseline in FVC at Week 52, measured in mL

    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.

    Measured: 52weeks

  2. Change from baseline in FVC % predicted at Weeks 24 and 52

    FVC (% predicted) was defined as forced vital capacity as a percentage of the predicted value.

    Measured: 24weeks、52weeks

  3. Change from baseline in FEV1 at Weeks 24 and 52, measured in mL/s

    FEV1 (ml/s)was defined as forced expiratory volume in one second.

    Measured: 24weeks、52weeks

  4. Change from baseline in FEV1 %predicted at Weeks 24 and 52

    FEV1 (% predicted)was forced expiratory volume in one second as a percentage of the predicted value .

    Measured: 24weeks、52weeks

  5. Change from baseline in TLC at Weeks 24 and 52, measured in mL

    TLC(ml) was defined as Total Lung Capacity.

    Measured: 24weeks、52weeks

  6. Change from baseline in TLC % predicted at Weeks 24 and 52

    TLC (% predicted) was defined as total lung capacity as a percentage of the predicted value.

    Measured: 24weeks、52weeks

  7. Change from baseline in DLco%predicted at Weeks 24 and 52

    DLco%predicted was diffusing capacity of the lung for carbon monoxide as a percentage of the predicted value.

    Measured: 24weeks、52weeks

  8. Change from baseline in 6-minute walk test at Weeks 24 and 52, measured in meters

    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.

    Measured: 24weeks、52weeks

  9. Change from baseline in HRCT-based fibrosis score at Weeks 24 and 52, as assessed by a prespecified imaging review method.

    Relative change from baseline in HRCT.

    Measured: 24weeks、52weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start28 Sep 2021
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828953
Sponsor's protocol ID
ky2021-128-01
Status last verified
Jun 2026
First submitted
27 Mar 2023
Last updated
5 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

    PubMed 21471066

  • Raghu G. Idiopathic pulmonary fibrosis: lessons from clinical trials over the past 25 years. Eur Respir J. 2017 Oct 26;50(4):1701209. doi: 10.1183/13993003.01209-2017. Print 2017 Oct.

    PubMed 29074545

  • Martinez FJ, Lederer DJ. Focus on Idiopathic Pulmonary Fibrosis: Advancing Approaches to Diagnosis, Prognosis, and Treatment. Chest. 2018 Oct;154(4):978-979. doi: 10.1016/j.chest.2018.08.1021.

    PubMed 30290930

  • Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012 Dec 1;21(126):355-61. doi: 10.1183/09059180.00002512.

    PubMed 23204124

  • Raghu G, Remy-Jardin M, Myers JL, Richeldi L, Ryerson CJ, Lederer DJ, Behr J, Cottin V, Danoff SK, Morell F, Flaherty KR, Wells A, Martinez FJ, Azuma A, Bice TJ, Bouros D, Brown KK, Collard HR, Duggal A, Galvin L, Inoue Y, Jenkins RG, Johkoh T, Kazerooni EA, Kitaichi M, Knight SL, Mansour G, Nicholson AG, Pipavath SNJ, Buendia-Roldan I, Selman M, Travis WD, Walsh S, Wilson KC; American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Society. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 1;198(5):e44-e68. doi: 10.1164/rccm.201807-1255ST.

    PubMed 30168753

  • Lederer DJ, Martinez FJ. Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 May 10;378(19):1811-1823. doi: 10.1056/NEJMra1705751. No abstract available.

    PubMed 29742380

  • Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, Devaraj A, Inoue Y, Le Maulf F, Richeldi L, Schmidt H, Walsh S, Mezzanotte W, Schlenker-Herceg R. Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease. BMJ Open Respir Res. 2017 Sep 17;4(1):e000212. doi: 10.1136/bmjresp-2017-000212. eCollection 2017.

    PubMed 29018526

  • Wells AU, Brown KK, Flaherty KR, Kolb M, Thannickal VJ; IPF Consensus Working Group. What's in a name? That which we call IPF, by any other name would act the same. Eur Respir J. 2018 May 17;51(5):1800692. doi: 10.1183/13993003.00692-2018. Print 2018 May.

    PubMed 29773608

  • Cottin V, Wollin L, Fischer A, Quaresma M, Stowasser S, Harari S. Fibrosing interstitial lung diseases: knowns and unknowns. Eur Respir Rev. 2019 Feb 27;28(151):180100. doi: 10.1183/16000617.0100-2018. Print 2019 Mar 31.

    PubMed 30814139

  • Kolb M, Vasakova M. The natural history of progressive fibrosing interstitial lung diseases. Respir Res. 2019 Mar 14;20(1):57. doi: 10.1186/s12931-019-1022-1.

    PubMed 30871560

  • Harari S, Caminati A. IPF: new insight on pathogenesis and treatment. Allergy. 2010 May;65(5):537-53. doi: 10.1111/j.1398-9995.2009.02305.x. Epub 2010 Feb 1.

    PubMed 20121758

  • Spagnolo P, Kropski JA, Jones MG, Lee JS, Rossi G, Karampitsakos T, Maher TM, Tzouvelekis A, Ryerson CJ. Idiopathic pulmonary fibrosis: Disease mechanisms and drug development. Pharmacol Ther. 2021 Jun;222:107798. doi: 10.1016/j.pharmthera.2020.107798. Epub 2020 Dec 24.

    PubMed 33359599

  • Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18.

    PubMed 24836310

  • Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

    PubMed 28993537

  • Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE Jr, Lancaster L, Sahn SA, Szwarcberg J, Valeyre D, du Bois RM; CAPACITY Study Group. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011 May 21;377(9779):1760-9. doi: 10.1016/S0140-6736(11)60405-4. Epub 2011 May 13.

    PubMed 21571362

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib in people with Interstitial Lung Diseases, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in forced vital capacity (FVC) at Week 24, measured in mL (time frame: 24weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05828953, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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