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Ulcerative Colitis (UC)Phase 1/2INT-210-II102NCT07692165

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

A Phase 1/2 study testing INT-210 Capsule in people with Ulcerative Colitis (UC), run by Innatus Therapeutics (Shanghai) Co., Ltd. at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
INT-210 Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
15 sitesChina
Study dates
11 Jun 2026to Jun 2028
Phase
Phase 1/2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the study and sign the informed consent form (ICF);
  • Males or females aged ≥18 and ≤75 years at the time of signing the ICF;
  • 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);
  • 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;
  • 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);
  • 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.;
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  • 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;
  • 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.

Who cannot join

  • Pregnant or lactating women, or those planning to become pregnant during the study;
  • Known allergy to any component of INT-210;
  • 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;
  • Participants who have undergone surgery for UC or are planning surgery (including stoma creation, or total or partial proctectomy/colectomy, etc.);
  • 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.
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  • With primary sclerosing cholangitis;
  • History of alcohol or drug abuse or addiction within one year prior to screening;
  • 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;
  • 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;
  • 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);
  • 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;
  • 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;
  • 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;
  • 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.);
  • 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;
  • 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;
  • Participants who have undergone small intestine or colon operation and have evidence of colonic dysplasia or intestinal stenosis;
  • 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);
  • Clinically significant electrocardiogram abnormal during the screening period, which the investigator judges may increase the participant's safety risk;
  • Have received any live vaccine within 3 months prior to randomization or plan to receive any live vaccine during the clinical study;
  • Participants whom the investigator considers have other factors that make them unsuitable for participation in this study.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Iris Liu contact

+86 010-82089858

irisliu@innatustherapeutics.com

15 sites in 1 country

China15 sites, 15 recruiting

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing

    Wang, +86 15333148249, yuna.wang@harvestiro.com

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

    Wang, +86 15333148249, yuna.wang@harvestiro.com

    Recruiting

  • Beijing Luhe Hospital, Capital Medical University

    Beijing

    Wang, +86 15333148249, yuna.wang@harvestiro.com

    Recruiting

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Li, +86 18620095814, lixia.li@harvestiro.com

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou

    Li, +86 18620095814, lixia.li@harvestiro.com

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

    Li, +86 18620095814, lixia.li@harvestiro.com

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    Huang, +86 13671708212, quinta.huang@harvestiro.com

    Recruiting

  • XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

    Huang, +86 13671708212, quinta.huang@harvestiro.com

    Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    Huang, +86 13671708212, quinta.huang@harvestiro.com

    Recruiting

  • Shanxi Bethune Hospital

    Taiyuan

    Wang, +86 15333148249, yuna.wang@harvestiro.com

    Recruiting

  • Weifang People's Hospital

    Weifang

    Huang, +86 13671708212, quinta.huang@harvestiro.com

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Huang, +86 13671708212, quinta.huang@harvestiro.com

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan

    Huang, +86 13671708212, quinta.huang@harvestiro.com

    Recruiting

  • Xijing Hospital (The First Affiliated Hospital of Air Force Medical University)

    Xi'an

    Wang, +86 15333148249, yuna.wang@harvestiro.com

    Recruiting

  • The First Affiliated Hospital of Henan Medical University

    Xinxiang

    Huang, +86 13671708212, quinta.huang@harvestiro.com

    Recruiting

Other trials in China

About this study

Official title: 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).

Being tested
INT-210 Capsule
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • INT-210 CapsuleDrug

    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).

  • INT-210 CapsuleDrug

    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)

Study groups in NCT07692165
Study groupRoleWhat they receive
200 mg INT-210 capsuleExperimentalNot described
Receives: Drug: INT-210 Capsule
400 mg INT-210 capsuleExperimentalNot described
Receives: Drug: INT-210 Capsule

What is being measured

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

  1. The incidence of treatment-emergent adverse events

    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.

    Measured: From enrollment through the safety follow-up visit on Day 92

  2. Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology

    Measured: From enrollment through the safety follow-up visit on Day 92

  3. Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: blood chemistry

    Measured: From enrollment through the safety follow-up visit on Day 92

  4. Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum ferritin

    Measured: From enrollment through the safety follow-up visit on Day 92

  5. Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation

    Measured: From enrollment through the safety follow-up visit on Day 92

  6. Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis

    Measured: From enrollment through the safety follow-up visit on Day 92

  7. Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)

    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.

    Measured: From enrollment through the safety follow-up visit on 92

  8. Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)

    Measured: From enrollment through the safety follow-up visit on Day 92

  9. Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)

    Measured: From enrollment through the safety follow-up visit on Day 92

  10. Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)

    Measured: From enrollment through the safety follow-up visit on Day 92

  11. Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)

    Measured: From enrollment through the safety follow-up visit on Day 92

Secondary outcomes (22)

  1. Pharmacokinetics parameter: Cmax of INT-210

    Maximum observed plasma concentration

    Measured: From Day 1 to Day 85

  2. Pharmacokinetics parameter: Cmax_ss of INT-210

    Peak Steady-state Concentration

    Measured: rom Day 1 to Day 85

  3. Pharmacokinetics parameter: Cmin_ss of INT-210

    Trough Steady-state Concentration

    Measured: From Day 1 to Day 85

  4. Pharmacokinetics parameter: Cave_ss of INT-210

    Average Steady-state Blood Drug Level

    Measured: From Day 1 to Day 85

  5. Pharmacokinetics parameter: AUC0-inf of INT-210

    Area under the curve from time 0 extrapolated to infinite time (AUCinf) of INT-210

    Measured: From Day1 to Day 85

  6. Pharmacokinetics parameter: AUC0-t of INT-210

    Area Under the Plasma Drug concentration-time Curve from Time 0 to the Last Measurement

    Measured: From Day 1 to Day 85

  7. Pharmacokinetics parameter: AUCss

    Area Under the Steady-state Blood drug Concentration-time Curve

    Measured: From Day 1 to Day 85

  8. Pharmacokinetics parameter: Tmax of INT-210

    Time of maximum observed concentration (Tmax)

    Measured: From Day 1 to Day 85

  9. Pharmacokinetics parameter: T1/2 of INT-210

    Half-life (T1/2) (hours)

    Measured: From Day 1 to Day 85

  10. Pharmacokinetics parameter: CL/F of INT-210

    Apparent Plasma Clearance

    Measured: From Day 1 to Day 85

  11. Pharmacokinetics parameter: Kel of INT-210

    Elimination Rate Constant

    Measured: From Day 1 to Day 85

  12. Pharmacokinetics parameter: MRT of INT-210

    Mean Residence Time

    Measured: From Day1 to Day 85

  13. Pharmacokinetics parameter: Vz/F of INT-210

    Apparent Volume of Distribution

    Measured: From Day 1 to Day 85

  14. Pharmacokinetics parameter: DF of INT-210

    Degree of Fluctuation

    Measured: From Day 1 to Day 85

  15. Pharmacokinetics parameter: RAAUC0-t of INT-210

    Accumulation Ratio Calculated Based on AUC

    Measured: From Day 1 to Day 85

  16. Pharmacokinetics parameter: RACmax of INT-210

    Accumulation Ratio Calculated Based on Cmax

    Measured: From Day 1 to Day 85

  17. Clinical Remission Rate

    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.

    Measured: From Day 0 to Day 85

  18. Clinical Response Rate

    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

    Measured: From Day 0 to Day 85

  19. Endoscopic Remission Rate

    The percentage of participants who, after taking INT-210, have an ES ≤1 (excluding "friability" assessment)

    Measured: From Day 0 to Day 85

  20. Histological Improvement Rate

    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).

    Measured: From Day 0 to Day 85

  21. Mucosal Healing Rate

    The percentage of participants who, after taking INT-210, have a GS ≤2B.1

    Measured: From Day 0 to Day 85

  22. Symptomatic Remission Rate

    The percentage of participants who, after taking INT-210, have an SFS = 0/1 and an RBS = 0.

    Measured: From Day 0 to Day 85

Timeline

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

  1. First posted9 Jul 2026
  2. Study start11 Jun 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692165
Sponsor's protocol ID
INT-210-II102
Other IDs
CTR20260703
Acronym
INT-210-II102
Status last verified
Jul 2026
First submitted
23 Jun 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INT-210 Capsule in people with Ulcerative Colitis (UC), run by Innatus Therapeutics (Shanghai) Co., Ltd. at 15 sites 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 39 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Iris Liu (+86 010-82089858, irisliu@innatustherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of treatment-emergent adverse events (time frame: From enrollment through the safety follow-up visit on Day 92). The study lists 11 primary outcomes in all. 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 NCT07692165.

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 9 Jul 2026.

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