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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.

Must not have

Malignancy within the last 5 years, excluding non-melanoma skin cancer.

Current medically significant infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My Crohn's disease is moderate to severe.

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I have not improved with standard treatments for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer other than non-melanoma skin cancer in the last 5 years.

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I do not have any serious infections right now.

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I have previously been treated with IL-2.

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I have had colorectal cancer or precancerous colon polyps.

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I have been diagnosed with ulcerative colitis.

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I need urgent surgery or intervention for a serious abdominal condition.

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I do not have severe heart problems like uncontrolled chest pain or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum effective dose

Number of subjects with serious and non-serious adverse events.

Secondary study objectives

Clinical Response

Immunological Response

Side effects data

From 2021 Phase 1 trial • 26 Patients • NCT02200445

100%

Injection site reaction

80%

fever

40%

achiness/chills

20%

strep throat

20%

Fatigue

20%

Hives

100%

80%

60%

40%

20%

Study treatment Arm

Interleukin-2 Dose C

Interleukin-2 Dose A

Interleukin-2 Dose B

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met