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A Phase Ib/IIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis (INT-210-II102)

2026. július 2. frissítette: Innatus Therapeutics (Shanghai) Co., Ltd.

A Multicenter, Randomized, Open-label Clinical Study to Evaluate the Safety and Efficacy of INT-210 Capsules in Participants With Active Ulcerative Colitis

A Multicenter, Randomized, Open-label Clinical Study to Evaluate the Safety and Efficacy of INT-210 Capsules in Participants with Active Ulcerative Colitis.

The study aims to evaluate the safety, efficacy, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics of INT-210 in participants with active ulcerative colitis (UC).

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

24

Fázis

  • 2. fázis
  • 1. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Kína
      • Beijing, Kína
        • Toborzás
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Kapcsolatba lépni:
      • Beijing, Kína
        • Toborzás
        • Beijing Friendship hospital, Capital Medical University
        • Kapcsolatba lépni:
      • Beijing, Kína
        • Toborzás
        • Beijing Luhe Hospital, Capital Medical University
        • Kapcsolatba lépni:
      • Guangzhou, Kína
        • Toborzás
        • The First Affiliated Hospital, Sun Yat-sen University
        • Kapcsolatba lépni:
      • Guangzhou, Kína
        • Toborzás
        • Guangzhou First People's Hospital
        • Kapcsolatba lépni:
      • Hangzhou, Kína
        • Toborzás
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Kapcsolatba lépni:
      • Shanghai, Kína
        • Toborzás
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Kapcsolatba lépni:
      • Taiyuan, Kína
        • Toborzás
        • Shanxi Bethune Hospital
        • Kapcsolatba lépni:
      • Weifang, Kína
      • Wenzhou, Kína
        • Toborzás
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Kapcsolatba lépni:
      • Wuhan, Kína
        • Toborzás
        • Renmin Hospital of Wuhan University
        • Kapcsolatba lépni:
      • Xi'an, Kína
        • Toborzás
        • Xijing Hospital (The First Affiliated Hospital of Air Force Medical University)
        • Kapcsolatba lépni:
      • Xinxiang, Kína
        • Toborzás
        • The First Affiliated Hospital of Henan Medical University
        • Kapcsolatba lépni:
    • Guangdong
      • Guangzhou, Guangdong, Kína
        • Toborzás
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Kapcsolatba lépni:
    • Liaoning
      • Shenyang, Liaoning, Kína
        • Toborzás
        • Shengjing Hospital of China Medical University
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

Inclusion Criteria:

  1. Voluntarily participate in the study and sign the informed consent form (ICF);
  2. Males or females aged ≥18 and ≤75 years at the time of signing the ICF;
  3. Diagnosed with UC for ≥3 months at the time of signing the ICF, with the diagnosis of UC supported by clinical manifestations and colonoscopy evidence, and confirmed by a histopathology report (pre-randomization colonoscopy and histopathology examination are acceptable as supporting evidence);
  4. Active UC, defined as: a modified Mayo score (including hematochezia, stool frequency, and endoscopy findings) of 4-9, with an endoscopy subscore of ≥2 (confirmed by central reading) and a hematochezia subscore of ≥1 in the Mayo score;
  5. At pre-randomization colonoscopy, the extent of UC lesions extends beyond the rectum (active disease ≥15 cm from the anal verge on colonoscopy, confirmed by central reading);
  6. Participants must have had an inadequate response or intolerance to at least one of the following UC treatments (inadequate response is defined as that the participant has previously discontinued the corresponding drug due to lack of efficacy as judged by the investigator; intolerance is defined as that the participant has previously discontinued the drug due to adverse reactions as judged by the investigator): oral sulfasalazine (SASP) and/or 5- aminosalicylate (5-ASA); oral corticosteroids; azathioprine or 6- mercaptopurine; marketed anti-tumor necrosis factor-α (TNF-α) agents: infliximab or adalimumab, etc.; vedolizumab; marketed JAK inhibitors: tofacitinib, upadacitinib, etc.; marketed interleukin 12/23 (IL-12/23) inhibitors: ustekinumab, etc.; selective sphingosine-1-phosphate (S1P) receptor modulators: etrasimod, etc.; sulfasalazine (SASP) and/or 5- aminosalicylate (5-ASA); oral corticosteroids; azathioprine or 6- mercaptopurine; marketed anti-tumor necrosis factor-α (TNF-α) agents: infliximab or adalimumab, etc.; vedolizumab; marketed JAK inhibitors: tofacitinib, upadacitinib, etc.; marketed interleukin 12/23 (IL-12/23) inhibitors: ustekinumab, etc.; selective sphingosine-1-phosphate (S1P) receptor modulators: etrasimod, etc.;

  7. If participants are currently using the following drugs to treat UC, they must also meet the following requirements:

    • Glucocorticoid therapy: oral prednisone ≤20 mg/d (or equivalent drug dose) or budesonide ≤9 mg/d or beclomethasone ≤5 mg/d, with a stable dose for at least 2 weeks before the screening colonoscopy;
    • Aminosalicylate preparations: oral sulfasalazine and/or 5- aminosalicylate must be stable for at least ≥2 weeks before the screening colonoscopy and must remain stable during the study;
  8. Throughout the entire study period from the signing of the ICF and for 3 months after the last dose, female participants of childbearing potential and male participants who have not undergone vasectomy must comply with the specified contraception requirements.

Exclusion Criteria:

  1. Pregnant or lactating women, or those planning to become pregnant during the study;
  2. Known allergy to any component of INT-210;
  3. Based on medical history and endoscopy and/or histological results, participants with suspected or confirmed Crohn's disease, unclassified colitis, acute fulminant colitis, toxic megacolon, intestinal perforation, microscopic colitis, ischemic colitis, or radiation colitis;
  4. Participants who have undergone surgery for UC or are planning surgery (including stoma creation, or total or partial proctectomy/colectomy, etc.);

  5. Evidence of unresected adenoma or dysplasia in the colon, including lowgrade or high-grade atypical hyperplasia, and unclassified atypical hyperplasia; presence of high-risk progressive adenoma, defined as:

    ① Adenoma diameter ≥10 mm; or ② Villous adenoma or mixed adenoma with villous structure exceeding 25%; or ③ Accompanied by high-grade intraepithelial neoplasia.

  6. With primary sclerosing cholangitis;
  7. History of alcohol or drug abuse or addiction within one year prior to screening;
  8. Have undergone other major surgery within 6 months prior to screening, or are planning surgery during the study; have a history of myocardial infarction, acute stroke or transient ischemic attack, thrombotic events such as deep vein thrombosis or pulmonary embolism, clinically significant arrhythmia or unstable angina pectoris, coronary artery bypass grafting, or severe or pulmonale or pulmonary arterial hypertension that would affect the evaluation of study results, within 6 months prior to screening;
  9. Presence of clinically severe diseases, such as a history of cardiovascular, hepatic, endocrine, gastrointestinal, metabolic, neurological, pulmonary, or psychiatric diseases, or clinically significant diseases, conditions, or other evidence that the investigator considers would pose a risk to participant safety or interfere with the conduct, progress, or completion of the study;
  10. Have received two or more classes of biological products/small molecule targeted drugs (e.g., anti-TNF-α monoclonal antibodies, anti-integrin antibodies, anti-IL12/23 monoclonal antibodies, JAK inhibitors, S1P receptor modulators) and have been assessed by the investigator as treatment failure (UC disease progression requiring salvage therapy, inability to taper glucocorticoid during the maintenance phase, or need for other effective therapies);

  11. Participants receiving the following drug therapies:

    • Use of non-steroidal anti-inflammatory drugs (excluding stable use of

      ≤100 mg/day aspirin for prevention of cardiovascular and cerebrovascular diseases and temporary use of ≤2000 mg/day acetaminophen for no more than three days for infectious pyrexia or mild to moderate pain), intestinal probiotics (including fecal transplant), fish oil, JAK inhibitors, immunoadsorption therapy, Chinese herbal medicines, or compound preparations containing Chinese herbal medicines within 2 weeks prior to randomization;

    • Use of azathioprine or 6-mercaptopurine, cyclosporine, thalidomide, methotrexate, mycophenolate, tacrolimus/sirolimus within 4 weeks prior to randomization;
    • Use of intravenous corticosteroids within 4 weeks prior to randomization, or rectal corticosteroids or rectal 5-ASA within 2 weeks prior to randomization;
    • Use of interferon or TNF-α inhibitors within 8 weeks prior to randomization;
    • Intravenous immunoglobulin injection or therapeutic plasma exchange within 8 weeks prior to randomization;
    • Use of S1P receptor modulators within 10 weeks prior to randomization;
    • Use of vedolizumab, IL-12/23 antibodies, cyclophosphamide, or chlorambucil within 12 weeks prior to randomization;
    • Use of leflunomide within 12 weeks prior to randomization, unless discontinued for 4 weeks before randomization and accelerated elimination (e.g., oral cholestyramine or activated charcoal) was completed at least 2 weeks prior to randomization, with corresponding medical history records required;
    • Use of rituximab within 1 year prior to randomization;
    • Use of any other investigational or marketed products with immunosuppressive effects within 8 weeks or 5 drug half-lives (whichever is longer) prior to randomization;
  12. Positive for Mycobacterium tuberculosis or judged by the investigator to have a potential M. tuberculosis infection, such as: positive T-SPOT.TB test or purified protein derivative (PPD) induration ≥5 mm (within 3 months prior to screening); chest imaging within 3 months prior to screening suggesting active tuberculosis infection lesions;
  13. History of recurrent invasive fungal infections or other chronic infections; herpes zoster or cytomegalovirus infection within 8 weeks prior to signing the ICF; clinically diagnosed clostridioides difficile infection or other intestinal infections within 30 days before the screening colonoscopy; positive clostridium test result during the screening period; infection requiring systemic anti-pathogen drugs (including antibacterial, antiviral, antifungal, anti-parasitic, etc.) for control within 7 days prior to randomization;
  14. Presence of any disease that may require treatment with systemic glucocorticoid during the study (e.g., moderate to severe asthma, dermatitis atopic, rheumatoid arthritis, etc.);
  15. Malignant tumors within 5 years prior to screening (except for adequately treated or resected basal cell or squamous cell skin cancer); or previous neoplasm screening that did not rule out tumor lesions;
  16. Participants with conditions that may affect the absorption of oral drugs, such as gastrectomy or clinically significant diabetes mellitus-related gastrointestinal diseases, or specific types of obesity surgery such as gastric bypass; participants who have only undergone simple gastric banding-like procedures that divide the stomach into separate pouches are not excluded;
  17. Participants who have undergone small intestine or colon operation and have evidence of colonic dysplasia or intestinal stenosis;

  18. Any of the following abnormalities in screening laboratory tests:

    • Hemoglobin <9 g/dL or white blood cells <3.0×109/L or neutrophils <1.5×109/L, platelets <100×109/L
    • Total bilirubin (TBIL), aspartate transaminase (AST), or alanine transaminase (ALT) ≥1.5 times the upper limit of normal (ULN)
    • Blood creatinine >1.5 times ULN
    • Any other abnormal laboratory test results that the investigator considers may expose the participant to unacceptable risks by participating in this study
    • Positive for hepatitis B surface antigen (HBsAg), or test results are HBsAg negative, hepatitis B core antibody (HBcAb) positive, and positive for hepatitis B virus deoxyribonucleic acid (HBV-DNA); positive for hepatitis C virus antibody (HCV-Ab) and positive for hepatitis C virus ribonucleic acid (HCV-RNA); positive for human immunodeficiency virus (HIV) antibody
    • Positive for intestinal pathogens (excluding colonizing microorganisms interpreted by the investigator to be non-pathogenic);
  19. Clinically significant electrocardiogram abnormal during the screening period, which the investigator judges may increase the participant's safety risk;
  20. Have received any live vaccine within 3 months prior to randomization or plan to receive any live vaccine during the clinical study;
  21. Participants whom the investigator considers have other factors that make them unsuitable for participation in this study.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 200 mg INT-210 capsule
Drog: INT-210 Capsule
All participants will receive oral treatment with INT-210 capsule 200 mg twice daily, starting from Day 1 (D1) of the treatment period (12 weeks).
Drog: INT-210 Capsule
All participants will receive oral treatment with INT-210 capsule 400 mg twice daily, starting from Day 1 (D1) of the treatment period (12 weeks)
Kísérleti: 400 mg INT-210 capsule
Drog: INT-210 Capsule
All participants will receive oral treatment with INT-210 capsule 200 mg twice daily, starting from Day 1 (D1) of the treatment period (12 weeks).
Drog: INT-210 Capsule
All participants will receive oral treatment with INT-210 capsule 400 mg twice daily, starting from Day 1 (D1) of the treatment period (12 weeks)

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
The incidence of treatment-emergent adverse events
Időkeret: From enrollment through the safety follow-up visit on Day 92
Number of participants with treatment-related adverse events as assessed. The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity.
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: blood chemistry
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum ferritin
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Időkeret: From enrollment through the safety follow-up visit on 92
A standard 12-lead ECG will be used to collect ventricular rate, PR interval, QRS duration, QT interval, QTcF interval (Fridericia's correction), and ECG result description; the participant must rest for at least 5 minutes before the test. The investigator (or designated personnel) will clinically evaluate each 12-lead ECG.
From enrollment through the safety follow-up visit on 92
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
Időkeret: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Pharmacokinetics parameter: Cmax of INT-210
Időkeret: From Day 1 to Day 85
Maximum observed plasma concentration
From Day 1 to Day 85
Pharmacokinetics parameter: Cmax_ss of INT-210
Időkeret: rom Day 1 to Day 85
Peak Steady-state Concentration
rom Day 1 to Day 85
Pharmacokinetics parameter: Cmin_ss of INT-210
Időkeret: From Day 1 to Day 85
Trough Steady-state Concentration
From Day 1 to Day 85
Pharmacokinetics parameter: Cave_ss of INT-210
Időkeret: From Day 1 to Day 85
Average Steady-state Blood Drug Level
From Day 1 to Day 85
Pharmacokinetics parameter: AUC0-inf of INT-210
Időkeret: From Day1 to Day 85
Area under the curve from time 0 extrapolated to infinite time (AUCinf) of INT-210
From Day1 to Day 85
Pharmacokinetics parameter: AUC0-t of INT-210
Időkeret: From Day 1 to Day 85
Area Under the Plasma Drug concentration-time Curve from Time 0 to the Last Measurement
From Day 1 to Day 85
Pharmacokinetics parameter: AUCss
Időkeret: From Day 1 to Day 85
Area Under the Steady-state Blood drug Concentration-time Curve
From Day 1 to Day 85
Pharmacokinetics parameter: Tmax of INT-210
Időkeret: From Day 1 to Day 85
Time of maximum observed concentration (Tmax)
From Day 1 to Day 85
Pharmacokinetics parameter: T1/2 of INT-210
Időkeret: From Day 1 to Day 85
Half-life (T1/2) (hours)
From Day 1 to Day 85
Pharmacokinetics parameter: CL/F of INT-210
Időkeret: From Day 1 to Day 85
Apparent Plasma Clearance
From Day 1 to Day 85
Pharmacokinetics parameter: Kel of INT-210
Időkeret: From Day 1 to Day 85
Elimination Rate Constant
From Day 1 to Day 85
Pharmacokinetics parameter: MRT of INT-210
Időkeret: From Day1 to Day 85
Mean Residence Time
From Day1 to Day 85
Pharmacokinetics parameter: Vz/F of INT-210
Időkeret: From Day 1 to Day 85
Apparent Volume of Distribution
From Day 1 to Day 85
Pharmacokinetics parameter: DF of INT-210
Időkeret: From Day 1 to Day 85
Degree of Fluctuation
From Day 1 to Day 85
Pharmacokinetics parameter: RAAUC0-t of INT-210
Időkeret: From Day 1 to Day 85
Accumulation Ratio Calculated Based on AUC
From Day 1 to Day 85
Pharmacokinetics parameter: RACmax of INT-210
Időkeret: From Day 1 to Day 85
Accumulation Ratio Calculated Based on Cmax
From Day 1 to Day 85
Clinical Remission Rate
Időkeret: From Day 0 to Day 85
The modified Mayo score (MMS) is uesd for assessing the disease activity of UC, including the Rectal Bleeding Subscore (RBS), Stool Frequency Subscore (SFS), and Endoscopy Subscore (ES). The score for each sub-item ranges from 0-3, and the total MMS score ranges from 0-9. A higher score indicates more severe disease, and the total score is a comprehensive assessment of active UC. The percentage of participants who, after taking INT-210, achieve a modified Mayo score ≤2, with an ES ≤1 (excluding "friability" assessment), RBS=0, SFS≤1, and with no increase from baseline in the above 3 subscores.
From Day 0 to Day 85
Clinical Response Rate
Időkeret: From Day 0 to Day 85
The percentage of participants who, after taking INT-210, have a decrease in their modified Mayo score of ≥2 points and ≥30% from baseline, and a decrease in RBS of ≥1 point or an absolute RBS of ≤1
From Day 0 to Day 85
Endoscopic Remission Rate
Időkeret: From Day 0 to Day 85
The percentage of participants who, after taking INT-210, have an ES ≤1 (excluding "friability" assessment)
From Day 0 to Day 85
Histological Improvement Rate
Időkeret: From Day 0 to Day 85
The percentage of participants who, after taking INT-210, achieve a Geboes Index Score (GS) ≤3.1, and an ES=0/1 in the MMS (excluding "friability" assessment).
From Day 0 to Day 85
Mucosal Healing Rate
Időkeret: From Day 0 to Day 85
The percentage of participants who, after taking INT-210, have a GS ≤2B.1
From Day 0 to Day 85
Symptomatic Remission Rate
Időkeret: From Day 0 to Day 85
The percentage of participants who, after taking INT-210, have an SFS = 0/1 and an RBS = 0.
From Day 0 to Day 85

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Innatus Therapeutics (Shanghai) Co., Ltd.

Nyomozók

  • Kutatásvezető: Minhu Chen, First Affiliated Hospital, Sun Yat-Sen University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. június 11.

Elsődleges befejezés (Becsült)

2028. június 1.

A tanulmány befejezése (Becsült)

2028. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. június 23.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 2.

Első közzététel (Tényleges)

2026. július 9.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. július 9.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. július 2.

Utolsó ellenőrzés

2026. július 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • INT-210-II102
  • CTR20260703 (Egyéb azonosító: National Medical Products Administration (NMPA))

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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