Vedolizumab for Immune Mediated Colitis

NCT04797325 | Unknown Phase 2 DMC

• 2 other identifiers: 010121212020-005793-10
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label randomized trial to evaluate the efficacy and treatment duration with vedolizumab to patients with immune mediated colitis. The trial will include 82 patients randomized into two arms, either standard treatment with prednisolone (plus infliximab in severe cases) or vedolizumab treatment up front.

Conditions

Immune-Mediated Colitis

Outcome Measures

Primary Outcomes (1)

• dose of prednisolone

  The cumulative dose of corticosteroids (tablets and IV) due to IrAE colitis at week 30

  Week 30

Secondary Outcomes (18)

• clinical remission

  week 2

• clinical remission

  week 10

• clinical remission

  week 30

• time to response

  30 days

• partial Mayo score

  week 2

Other Outcomes (6)

• T-cell response

  Change from week 0 to week 15.

• pharmacogenomic

  week 0 to week 30

• Omics

  week 0 to week 30.

Study Arms (2)

vedolizumab

ACTIVE COMPARATOR

Drug: Vedolizumab

Standard treatment

ACTIVE COMPARATOR

Drug: Prednisolone

Interventions

Vedolizumab DRUG

Repeatedly vedolizumab infusion at week 0, 2, 6, 14, 22

vedolizumab

Prednisolone DRUG

tablet prednisolone plus infliximab in severe cases.

Also known as: Infliximab

Standard treatment

Eligibility Criteria

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

You may qualify if:

• Patients with solid tumors treated with PD-1, PD-L1 and /or CTLA-4 inhibitors and where IrAE colitis is preventing further treatment with check point inhibitors
• IrAE colitis where the oncologist suggests treatment with tablet or IV corticosteroids (prednisolone or equivalent)
• Negative pregnancy test in fertile women
• Age ≥ 18.

You may not qualify if:

• Any ongoing infectious disease, including GI infections
• Neutropenia within the last month
• Known allergy towards vedolizumab or Infliximab
• Severe heart failure, NYHA grade 3-4
• Colorectal cancer
• Other IrAEs requiring systemic treatment with either prednisolone (\> 10 mg daily or equivalents) or other immunosuppressive medications within 14 days before study drug administration
• Females of childbearing potential or males of reproductive potential who are not willing to use an effective method of contraception, such as oral, injected, or implanted hormonal methods of contraception, intrauterine device or intrauterine system, condom in combination with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, creamer suppository, male sterilization, or true abstinence throughout study and for a minimum of 3 months after study drug therapy

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Herlev University Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Interventions

vedolizumab; Prednisolone; Infliximab

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jakob B Seidelin, professor

  University of Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Emilie Dahl

CONTACT

+4538686391; emilie.kristine.dahl@regionh.dk

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: Medical Doctor, phd student

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 15, 2021
• Study Start: August 30, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)