Acute Severe Ulcerative ColitisPhase 2NCT07297069
Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial
A Phase 2 study testing Infliximab and Tofacitinib in people with Acute Severe Ulcerative Colitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
In adults hospitalized with acute severe ulcerative colitis who fail to respond to intravenous steroids, does treatment with a combination of infliximab and tofacitinib, compared with infliximab alone or tofacitinib alone, result in higher rates of early clinical remission and mucosal healing, and fewer… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Severe Ulcerative Colitis
- What is being tested?
- Infliximab and Tofacitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2026to 31 Dec 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (aged 18 years to 65 years) patients hospitalised due to ASUC
Who cannot join
- Patients with UC who did not meet the Truelove Witts criteria for ASUC.
- Patients who are already on Tofacitinib / Infliximab.
- Latent or active tuberculosis.
- Crohn's or Indeterminate colitis.
- Mega colon (if the diameter of the transverse colon is 5.5 cm or more, with apparent oedema of the bowel wall on plain abdominal radiographs).
- Pseudomembranous colitis or concomitant CMV colitis.
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- Intestinal perforation.
- Massive haemorrhage requiring emergency colectomy.
- Pregnant or lactating female individuals.
- Current diagnosis or history of thromboembolic disease patients with severe cardiorespiratory, renal or hepatic Co morbidities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
Vamsi Krishna Ankam, DrNB(medical gastroenterology), +91 9705904243, Vamsiankam999@gmail.com
Pardhu Bharath Neelam, DM(medical gastroenterology), +91 7799456166, Drpardhu.bharath@gmail.com
About this study
Official title: Combination of INFLIXIMAB With TOFACITINIB in ASUC - CINTO Trial
In adults hospitalized with acute severe ulcerative colitis who fail to respond to intravenous steroids, does treatment with a combination of infliximab and tofacitinib, compared with infliximab alone or tofacitinib alone, result in higher rates of early clinical remission and mucosal healing, and fewer treatment-related complications over a 10 week period
Read the detailed description
Acute severe ulcerative colitis (ASUC) is a life threatening manifestation of ulcerative colitis that requires urgent medical treatment and hospitalization. Despite the use of rapid induction intravenous corticosteroids, some patients fail to respond and require rescue therapy. Infliximab is commonly used as rescue treatment; however, its effectiveness may be reduced in patients with severe inflammation and hypoalbuminemia. As a result, colectomy rates for ASUC remain significant and improved early rescue strategies are needed.
Tofacitinib is an oral Janus kinase inhibitor that targets multiple cytokine pathways involved in ulcerative colitis. It has a rapid onset of action and has shown benefit in severe and steroid-refractory disease. Because infliximab and tofacitinib act on different immunologic targets, their combined use may provide complementary therapeutic effects. Emerging observational data suggest that combining a biologic agent with a small-molecule therapy may be safe and potentially more effective in patients with severe disease who are at high risk for treatment failure.
This study is designed to explore whether the combination of infliximab and tofacitinib offers greater early clinical benefit compared to infliximab alone, tofacitinib alone for adults hospitalized with ASUC who do not respond to intravenous corticosteroids.The goal is to generate preliminary data that may inform future treatment approaches aimed at improving remission rates, accelerating mucosal healing, and reducing the need for colectomy in this high risk population.
- Conditions
- Acute Severe Ulcerative Colitis
- Being tested
- Infliximab, Tofacitinib
- Keywords
- Rescue therapy, Combination therapy, Steroid refractory ulcerative colitis, Infliximab, Tofacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab as rescue therapy. Infliximab 300 mg will be administered intravenously. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing.
TofacitinibDrug
Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab Plus Tofacitinib | Experimental | Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive combination therapy with infliximab and tofacitinib. Infliximab 300 mg will be given intravenously, and tofacitinib will be administered orally at 10 mg twice daily. This arm evaluates whether combination therapy produces enhanced early clinical improvement and offers greater effectiveness and safety in inducing early clinical remission and mucosal healing compared with either agent alone. Receives: Drug: Infliximab; Drug: Tofacitinib |
| Infliximab Only | Active comparator | Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab alone as rescue therapy. Infliximab will be administered at a dose of 300 mg intravenously according to protocol. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing. Receives: Drug: Infliximab |
| Tofacitinib Only | Active comparator | Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib alone as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing. Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission Rate
Clinical remission is defined as defined as a Mayo score ≤2 and no individual subscore >1.Participants meeting these criteria will be classified as achieving clinical remission.
Measured: Week 1 and Week 4
Secondary outcomes (3)
Clinical Response Rate
Reduction of baseline Mayo score by ≥3 points and a decrease of 30% from the baseline score with a decrease of at least one point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.
Measured: Week 1 and Week 4
Mucosal Healing Rate
Mucosal healing is defined as an endoscopic Mayo score of 0 or 1 on flexible sigmoidoscopy. Participants undergoing endoscopic evaluation who meet these criteria will be classified as achieving mucosal healing.
Measured: Week 4 and Week 12
Treatment Related Adverse Events
Adverse events related to study medications, including but not limited to infections, lymphocytopenia, thromboembolic events, hyperlipidemia, and infusion or drug-related reactions, will be recorded throughout the study period. Severity and relationship to the study intervention will be assessed.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Severe Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Three arm parallel randomized pilot trial comparing infliximab alone, tofacitinib alone, and combination therapy with infliximab plus tofacitinib in adults hospitalized with acute severe ulcerative colitis who do not respond to intravenous corticosteroids.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Vamsi Krishna Ankam, DrNB(gastroenterology), Principal investigator, Asian Institute of Gastroenterology, Hyderabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297069
- Sponsor's protocol ID
- CINTO 1
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because data sharing is not planned for this study.
Publications
Hickman K, Jordan R, Sonnier W. Combination biologic and small molecule therapy for refractory ulcerative colitis. Gastroenterology. 2022;162(3 Suppl):S103.
A genome-scale CRISPR tool for targeting multiple gene family members at once. Nat Plants. 2023 Apr;9(4):511-512. doi: 10.1038/s41477-023-01388-y. No abstract available.
PubMed 36973416
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of INFLIXIMAB With TOFACITINIB in ASUC - CINTO Trial
- ClinicalTrials.gov ID
- NCT07297069
- Acronym / sponsor ID
- CINTO 1
- Conditions
- Acute Severe Ulcerative Colitis
- Keywords
- Rescue therapy, Combination therapy, Steroid refractory ulcerative colitis, Infliximab, Tofacitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In adults hospitalized with acute severe ulcerative colitis who fail to respond to intravenous steroids, does treatment with a combination of infliximab and tofacitinib, compared with infliximab alone or tofacitinib alone, result in higher rates of early clinical remission and mucosal healing, and fewer treatment-related complications over a 10 week period
Detailed description
Acute severe ulcerative colitis (ASUC) is a life threatening manifestation of ulcerative colitis that requires urgent medical treatment and hospitalization. Despite the use of rapid induction intravenous corticosteroids, some patients fail to respond and require rescue therapy. Infliximab is commonly used as rescue treatment; however, its effectiveness may be reduced in patients with severe inflammation and hypoalbuminemia. As a result, colectomy rates for ASUC remain significant and improved early rescue strategies are needed.
Tofacitinib is an oral Janus kinase inhibitor that targets multiple cytokine pathways involved in ulcerative colitis. It has a rapid onset of action and has shown benefit in severe and steroid-refractory disease. Because infliximab and tofacitinib act on different immunologic targets, their combined use may provide complementary therapeutic effects. Emerging observational data suggest that combining a biologic agent with a small-molecule therapy may be safe and potentially more effective in patients with severe disease who are at high risk for treatment failure.
This study is designed to explore whether the combination of infliximab and tofacitinib offers greater early clinical benefit compared to infliximab alone, tofacitinib alone for adults hospitalized with ASUC who do not respond to intravenous corticosteroids.The goal is to generate preliminary data that may inform future treatment approaches aimed at improving remission rates, accelerating mucosal healing, and reducing the need for colectomy in this high risk population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three arm parallel randomized pilot trial comparing infliximab alone, tofacitinib alone, and combination therapy with infliximab plus tofacitinib in adults hospitalized with acute severe ulcerative colitis who do not respond to intravenous corticosteroids.
| Arm | Type | Receives |
|---|---|---|
| Infliximab Plus Tofacitinib | Experimental | Drug: Infliximab, Drug: TofacitinibParticipants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive combination therapy with infliximab and tofacitinib. Infliximab 300 mg will be given intravenously, and tofacitinib will be administered orally at 10 mg twice daily. This arm evaluates whether combination therapy produces enhanced early clinical improvement and offers greater effectiveness and safety in inducing early clinical remission and mucosal healing compared with either agent alone. |
| Infliximab Only | Active comparator | Drug: InfliximabParticipants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab alone as rescue therapy. Infliximab will be administered at a dose of 300 mg intravenously according to protocol. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing. |
| Tofacitinib Only | Active comparator | Drug: TofacitinibParticipants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib alone as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (aged 18 years to 65 years) patients hospitalised due to ASUC
Key exclusion criteria (10 listed)
- Patients with UC who did not meet the Truelove Witts criteria for ASUC.
- Patients who are already on Tofacitinib / Infliximab.
- Latent or active tuberculosis.
- Crohn's or Indeterminate colitis.
- Mega colon (if the diameter of the transverse colon is 5.5 cm or more, with apparent oedema of the bowel wall on plain abdominal radiographs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabParticipants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab as rescue therapy. Infliximab 300 mg will be administered intravenously. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing. | Drug | Infliximab Only, Infliximab Plus Tofacitinib |
| TofacitinibParticipants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing. | Drug | Infliximab Plus Tofacitinib, Tofacitinib Only |
Primary outcome
Clinical Remission Rate
Time frame: Week 1 and Week 4
Clinical remission is defined as defined as a Mayo score ≤2 and no individual subscore >1.Participants meeting these criteria will be classified as achieving clinical remission.
3 secondary outcomes
Clinical Response Rate
Time frame: Week 1 and Week 4
Mucosal Healing Rate
Time frame: Week 4 and Week 12
Treatment Related Adverse Events
Time frame: Baseline through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- BackgroundHickman K, Jordan R, Sonnier W. Combination biologic and small molecule therapy for refractory ulcerative colitis. Gastroenterology. 2022;162(3 Suppl):S103.
- Background: PubMed 36973416A genome-scale CRISPR tool for targeting multiple gene family members at once. Nat Plants. 2023 Apr;9(4):511-512. doi: 10.1038/s41477-023-01388-y. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because data sharing is not planned for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vamsi Krishna Ankam, DrNB(gastroenterology) principal investigator
Asian Institute of Gastroenterology, Hyderabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infliximab and Tofacitinib in people with Acute Severe Ulcerative Colitis, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 1 inclusion and 10 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: opening soon, as of the sponsor's last update on 24 Dec 2025. 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 India. 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 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?
Contact Vamsi Krishna Ankam, DrNB(medical gastroenterology) (+91 9705904243, Vamsiankam999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission Rate (time frame: Week 1 and Week 4). 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 NCT07297069, which also lists 2 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 24 Dec 2025.