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

2. juli 2026 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 200 mg INT-210 capsule
Medicin: 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).
Medicin: 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)
Eksperimentel: 400 mg INT-210 capsule
Medicin: 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).
Medicin: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of treatment-emergent adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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 (℃)
Tidsramme: From enrollment through the safety follow-up visit on Day 92
From enrollment through the safety follow-up visit on Day 92

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics parameter: Cmax of INT-210
Tidsramme: From Day 1 to Day 85
Maximum observed plasma concentration
From Day 1 to Day 85
Pharmacokinetics parameter: Cmax_ss of INT-210
Tidsramme: rom Day 1 to Day 85
Peak Steady-state Concentration
rom Day 1 to Day 85
Pharmacokinetics parameter: Cmin_ss of INT-210
Tidsramme: From Day 1 to Day 85
Trough Steady-state Concentration
From Day 1 to Day 85
Pharmacokinetics parameter: Cave_ss of INT-210
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From Day 1 to Day 85
Half-life (T1/2) (hours)
From Day 1 to Day 85
Pharmacokinetics parameter: CL/F of INT-210
Tidsramme: From Day 1 to Day 85
Apparent Plasma Clearance
From Day 1 to Day 85
Pharmacokinetics parameter: Kel of INT-210
Tidsramme: From Day 1 to Day 85
Elimination Rate Constant
From Day 1 to Day 85
Pharmacokinetics parameter: MRT of INT-210
Tidsramme: From Day1 to Day 85
Mean Residence Time
From Day1 to Day 85
Pharmacokinetics parameter: Vz/F of INT-210
Tidsramme: From Day 1 to Day 85
Apparent Volume of Distribution
From Day 1 to Day 85
Pharmacokinetics parameter: DF of INT-210
Tidsramme: From Day 1 to Day 85
Degree of Fluctuation
From Day 1 to Day 85
Pharmacokinetics parameter: RAAUC0-t of INT-210
Tidsramme: From Day 1 to Day 85
Accumulation Ratio Calculated Based on AUC
From Day 1 to Day 85
Pharmacokinetics parameter: RACmax of INT-210
Tidsramme: From Day 1 to Day 85
Accumulation Ratio Calculated Based on Cmax
From Day 1 to Day 85
Clinical Remission Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Innatus Therapeutics (Shanghai) Co., Ltd.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • INT-210-II102
  • CTR20260703 (Anden identifikator: National Medical Products Administration (NMPA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Colitis ulcerosa (UC)

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