A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Vedolizumab — DRUG
  Vedolizumab IV infusions
• Tofacitinib — DRUG
  Tofacitinib Tablets

Study Details

The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.

Key Dates

Start date

Jun 12, 2024

Status verified

Mar 2026

Primary completion

Jul 9, 2027

Completion

Jul 9, 2027

Study Design

Enrollment

65 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Vedolizumab 300 mg + Tofacitinib 10 mg
  Participants will receive Vedolizumab 300 mg, intravenous (IV) infusion, at Week 0, Week 2 and Week 6 along with Tofacitinib 10 mg, tablets, orally, twice daily from Week 0 to Week 8. Participants with clinical response at Week 8 will transition to receive vedolizumab 300 mg IV infusion every 8 weeks (Q8W) through Week 46.

Primary Outcome Measure

Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score [ Time Frame: At Week 8 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (40)

Find similar trials in Dothan, AL

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