Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial

NCT07297069 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CINTO 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 treatment-related complications over a 10 week period

Conditions

Acute Severe Ulcerative Colitis

Keywords

Rescue therapy; Combination therapy; Steroid refractory ulcerative colitis; Infliximab; Tofacitinib

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 1 and Week 4

Secondary Outcomes (3)

• Clinical Response Rate

  Week 1 and Week 4

• Mucosal Healing Rate

  Week 4 and Week 12

• Treatment Related Adverse Events

  Baseline through Week 12

Study Arms (3)

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.

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.

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.

Drug: Tofacitinib

Interventions

Infliximab DRUG

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.

Infliximab Only; Infliximab Plus Tofacitinib

Tofacitinib DRUG

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.

Infliximab Plus Tofacitinib; Tofacitinib Only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (aged 18 years to 65 years) patients hospitalised due to ASUC

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

Related Publications (2)

• Hickman K, Jordan R, Sonnier W. Combination biologic and small molecule therapy for refractory ulcerative colitis. Gastroenterology. 2022;162(3 Suppl):S103.

  BACKGROUND

• 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.

  PMID: 36973416 BACKGROUND

MeSH Terms

Interventions

Infliximab; tofacitinib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Vamsi Krishna Ankam, DrNB(gastroenterology)

  Asian Institute of Gastroenterology, Hyderabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vamsi Krishna Ankam, DrNB(medical gastroenterology)

CONTACT

+91 9705904243; Vamsiankam999@gmail.com

Pardhu Bharath Neelam, DM (gastroenterology)

CONTACT

+91 7799456166; Drpardhu.bharath@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)