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Cytokine
Low Dose IL-2 for Crohn's Disease
Phase 1 & 2
Recruiting
Led By Scott Snapper, MD, PhD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult subjects with moderate-to-severe CD (CDAI score 220-450)
Failure to tolerate or failure to respond to at least one conventional therapy with the intention of inducing or maintaining remission (including but not limited to oral corticosteroids, oral 5-aminosalicylates, azathioprine and/or 6-mercaptopurine, TNF alpha antagonist, anti-integrins, ustekinumab). Corticosteroid dependency (inability to taper oral corticosteroids without a recurrence of disease activity) is also included in this category.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a possible new treatment for Crohn's Disease, by testing how safe and effective it is.
Who is the study for?
Adults aged 18-80 with moderate-to-severe Crohn's Disease, not responding to conventional therapies, can join this trial. They must have endoscopic inflammation and no recent biologic medication use. Exclusions include other bowel diseases, significant infections or lab abnormalities, certain cancers within 5 years, pregnancy, and inability to consent.Check my eligibility
What is being tested?
The trial is testing the safety and maximum effective dose of Interleukin-2 (aldesleukin) for treating Crohn's Disease. It aims to find out how well it works in patients who haven't had success with standard treatments.See study design
What are the potential side effects?
Interleukin-2 may cause side effects like flu-like symptoms (fever, chills), fatigue, rash, itching, nausea or vomiting. Some people might experience low blood pressure or changes in heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Crohn's disease is moderate to severe.
Select...
I have not improved with standard treatments for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum effective dose
Number of subjects with serious and non-serious adverse events.
Secondary outcome measures
Clinical Response
Immunological Response
Side effects data
From 2021 Phase 1 trial • 26 Patients • NCT02200445100%
Injection site reaction
80%
fever
40%
achiness/chills
20%
strep throat
20%
Fatigue
20%
Hives
100%
80%
60%
40%
20%
0%
Study treatment Arm
Interleukin-2 Dose C
Interleukin-2 Dose A
Interleukin-2 Dose B
Trial Design
1Treatment groups
Experimental Treatment
Group I: Interleukin-2Experimental Treatment1 Intervention
Study drug: Interleukin-2 (aldesleukin, Proleukin, IL-2).
Each subject will receive an 8-week course of once-daily, subcutaneously administered IL-2. There will be two dose cohorts. Each subject will be recruited into a single dose cohort and receive a single dose level of IL-2 throughout the study.
The dose levels will be as follows:
Cohort 1: 1.0x10^6 IU/m^2/day. Cohort 2: 1.25x10^6 IU/m^2/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2 (aldesleukin).
2015
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,700 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,562 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,846 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Crohn's disease is moderate to severe.I have had cancer other than non-melanoma skin cancer in the last 5 years.I have not improved with standard treatments for my condition.I do not have any serious infections right now.I have previously been treated with IL-2.I have had colorectal cancer or precancerous colon polyps.My stool frequency is measured by how often I empty my bag.I haven't taken any biologic medication in the last 4 weeks.My stool test for C. difficile was positive using the GDH/EIA method.I am between 18 and 80 years old, or under 30 if treated at BCH.My bilirubin levels are high, but it's due to Gilbert's syndrome.I can make my own healthcare decisions or have a guardian who can.I have been diagnosed with ulcerative colitis.I need urgent surgery or intervention for a serious abdominal condition.I am not pregnant and agree to use birth control during and 6 months after treatment.I do not have severe heart problems like uncontrolled chest pain or heart failure.You are allergic to any ingredient in the study medication.
Research Study Groups:
This trial has the following groups:- Group 1: Interleukin-2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to participate in this research?
"Qualified participants for this study must have ileocolitis and be within the ages of 18 to 80. Currently, the clinical trial is looking to enroll 30 individuals."
Answered by AI
Is this experiment still recruiting individuals?
"Yes, this trial is open and recruiting patients as of right now.3/11/2021 was the date when the listing was first published while 5/18/2022 reflects the most recent update. The investigators running the study need to enroll a total of 30 individuals at 3 different research locations."
Answered by AI
Could you please tell me if aldesleukin has been studied before?
"At the moment, there are 62 ongoing studies researching Interleukin-2 (aldesleukin). Of these research projects, 5 are in Phase 3. Many of the trials for Interleukin-2 (aldesleukin) take place in Boston, Massachusetts; however, there 400 locations across the country running similar studies."
Answered by AI
How many people are being studied in this clinical trial?
"That is correct. According to the listing on clinicaltrials.gov, this study began recruiting on March 11th, 2021 and is still looking for 30 patients from 3 separate locations."
Answered by AI
Does this research project allow for elderly participants?
"This particular clinical trial is for individuals aged 18 to 80. There are 80 other trials available for children and 253 different ones for seniors."
Answered by AI
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