Vedolizumab-4054

Recruiting

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

Clinicaltrials.gov

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.

Interventional Phase 4 clinical trial.

What medical conditions are being studied?

Ulcerative Colitis

What is the clinical trial testing?

Vedolizumab, Tofacitinib

How many participants are being enrolled?

Are placebos part of the clinical trial?

When is the clinical trial being conducted?

Jun 2024 - Jul 2027

How long is participation in the clinical trial?

Participants will be in this study for up to 72 weeks

Sexes

All

Age

18-65 years

Healthy volunteers?

Men and women aged 18 to 65 years can participate in the study.

Must have ulcerative colitis (UC) for at least 3 months before the study.

Must have moderate or severe UC

Must have proof of UC extending close to the anus.

Cannot have acute serious UC, parts of their bowel removed (colon resection), an abscess in the belly (abdominal abscess), or short bowel syndrome.

Cannot have Crohn's disease or a condition that affects bile duct.

Cannot have received an infusion of antibiotics within 8 weeks of treatment in the study and cannot have received any treatment of UC via the anus within 2 weeks of participation in the study.

Cannot have undergone surgery that required general anesthesia within 3 months of study participation.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

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

Secondary outcome measures

Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo Score [Time Frame: At Week 52]

Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo Score [Time Frame: At Weeks 8, 14 and 26]

Percentage of Participants Achieving Clinical Response at Weeks 2, 6, 8, 14, 26 and 52 Based on Complete or Partial Mayo Score [Time Frame: At Weeks 2, 6, 8, 14, 26, and 52]

Percentage of Participants Achieving Clinical Remission at Week 8 and Week 52 Based on Modified Mayo Score [Time Frame: At Weeks 8 and 52]

Percentage of Participants With Durable Clinical Remission at Week 8 and Week 52 [Time Frame: At Week 8 and Week 52]

Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 8 [Time Frame: At Week 8]

Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 8 [Time Frame: At Week 8]

Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 52 [Time Frame: At Week 52]

Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 52 [Time Frame: At Week 52]

Percentage of Participants Achieving Clinical Response at Week 8 [Time Frame: At Week 8]

Percentage of Participants With Mucosal Healing Based on MES at Week 52 [Time Frame: At Week 52]

Percentage of Participants With Histological Remission Based on Geboes Score at Week 52 [Time Frame: At Week 52]

Change in C-Reactive Protein Levels (CRP) From Baseline [Time Frame: Baseline to Weeks 2, 6, 8, 14, 26, 42 and 52]

Change in Fecal Calprotectin Concentrations From Baseline [Time Frame: Baseline to Weeks 2, 6, 8, 14, 26, 42 and 52]

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline [Time Frame: At Weeks 8, 26 and 52]

Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline [Time Frame: At Weeks 8, 26 and 52]

Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs) [Time Frame: Up to 76 Weeks]

Number of Participants With Clinically Significant Change in Vital Signs From Baseline [Time Frame: Up to 76 Weeks]

Number of Participants With Clinically Significant Physical Examination Findings [Time Frame: At Baseline and From Week 14 to Week 72]

Number of Participants With Markedly Abnormal Laboratory Values [Time Frame: Up to Week 76]