← Back to Search

Monoclonal Antibodies

Tildrakizumab for Graft-versus-Host Disease

Phase 2

Waitlist Available

Led By Lyndsey Runaas, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Estimated creatinine clearance ≥40 mL/minute (using the Cockcroft-Gault formula and actual body weight)

Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (adjusted for hemoglobin) and forced expiratory volume in 1 second (FEV1) ≥50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test if tildrakizumab can improve survival rates for people with hematologic malignancy who have undergone allogeneic hematopoietic cell transplantation.

Who is the study for?

Adults over 18 with blood cancers eligible for a bone marrow transplant can join. They need a matched donor, good heart and kidney function, and no severe infections or uncontrolled illnesses. Women must use contraception or be postmenopausal/surgically sterile.Check my eligibility

What is being tested?

The trial tests Tildrakizumab's effectiveness in preventing acute graft-versus-host disease after a myeloablative allogeneic hematopoietic cell transplantation for treating blood cancer.See study design

What are the potential side effects?

Tildrakizumab may cause immune system reactions, potential infection risks, allergic responses, and could affect liver enzymes. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidneys are functioning well enough for treatment.

Select...

My lung function tests show I can breathe well enough.

Select...

I have a donor who matches me closely for a transplant.

Select...

I am 18 years old or older.

Select...

My heart pumps well enough for intensive cancer treatment.

Select...

My liver tests are within the required limits.

Select...

My stem cell transplant will use a full set of T cells.

Select...

I have a blood cancer suitable for a stem cell transplant and meet the specific remission criteria.

Select...

I have undergone intensive treatment to prepare for a bone marrow transplant.

Select...

I have had surgery to remove my uterus and/or both ovaries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

GVHD-free Relapse-Free Survival

Secondary outcome measures

Disease Relapse or Progression

Hematopoietic recovery according to neutrophil count recovery

Hematopoietic recovery according to platelet count recovery

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TildrakizumabExperimental Treatment1 Intervention

Tildrakizumab (IluymaTM) is a humanized monoclonal antibody that specifically binds to the IL-23p19 subunit of IL-23 to neutralize its function.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tildrakizumab

FDA approved

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,532 Total Patients Enrolled

Lyndsey Runaas, MDPrincipal Investigator - Medical College of Wisconsin

Froedtert & The Medical College of Wisconsin

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04112810 — Phase 2

Blood Cancers Research Study Groups: Tildrakizumab

Blood Cancers Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT04112810 — Phase 2

Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04112810 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a trial like this ever been conducted before?

"Presently, the world is hosting 10 separate clinical trials for Tildrakizumab across 52 cities in 9 distinct countries. Sun Pharma Global FZE kicked off this series of research back in 2020 with a study involving 120 participants who completed Phase 2 & 3 drug approval stages. Subsequent to that initial effort, there have been 7 more studies conducted over the past two years."

Answered by AI

Is Tildrakizumab promotion of well-being accompanied by any adverse effects?

"Assessed on a scale of 1-3, our team at Power considers Tildrakizumab to be moderately safe given the Phase 2 trial data we have obtained thus far which attests to its safety but not efficacy."

Answered by AI

How many participants are eligible for this clinical research?

"Affirmative, clinicaltrials.gov illustrates that this research study is currently seeking patients. It was first uploaded on March 1st 2020 and edited lastly on September 12th 2022. 55 individuals are required from a single site."

Answered by AI

Does this experiment currently have an open enrollment period?

"Affirmative. The clinical trial data found on clinicaltrials.gov indicates that this experiment is still taking part in the enrollment of participants, with recruitment beginning on March 1st 2020 and most recently updated on September 12th 2022. They are currently accepting 55 patients from a single site."

Answered by AI

Has there been any prior research conducted using Tildrakizumab?

"To date, 10 clinical trials are being conducted to investigate the efficacy of Tildrakizumab. 2 of these studies have now advanced into Phase 3 and 106 locations across America are involved in the research process. Milwaukee is a primary hub for this treatment's testing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease

Lyndsey Runaas 2020. "Tildrakizumab for Prevention of Acute Graft-Versus-Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04112810.

All > Graft Vs Host Disease