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New treatment option for Crohn Disease
Official title Low Dose IL-2 for the Treatment of Crohn's Disease
ClinicalTrials.gov ID: NCT04263831
What this study is testing
What is Interleukin-2 (aldesleukin).?
Interleukin-2 (aldesleukin). is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for crohn disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe crohn's disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 80
You may be able to join if
- Age 12-80 years. Maximum age limit for people recruited at BCH will be 30 years.
- A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria. a. A subset of patients with Ileostomies or...
- Adult people with moderate-to-severe CD (CDAI score 220-450) a. a modified CDAI will be used to assess patients with ileostomies/colostomies. Number...
- Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy
- Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease
You likely can't join if
- A diagnosis of ulcerative colitis or indeterminate colitis.
- Requirement for immediate surgical, endoscopic or radiological intervention for perforation, sepsis, or intra-abdominal or perianal abscess.
- History of colorectal cancer or dysplasia.
- Positive stool test for Clostridium difficile via GDH/EIA two step testing method. PCR only testing will not be accepted. If patient is GDH positive...
- Current medically significant infection.
- Significant laboratory abnormalities;
See the full eligibility criteria
- Age 12-80 years. Maximum age limit for people recruited at BCH will be 30 years.
- A diagnosis of CD made by standard clinical, radiological, endoscopic and histological criteria. a. A subset of patients with Ileostomies or colostomies will be permitted.
- Adult people with moderate-to-severe CD (CDAI score 220-450) a. a modified CDAI will be used to assess patients with ileostomies/colostomies. Number of liquid stools per day will be substituted for number of bag empties...
- Evidence of endoscopic inflammation accessible via ileocolonoscopy or ileoscopy
- Simple Endoscopic Score for CD (SES-CD) ≥ 6 or ≥ 4 for isolated ileal disease
- patients with ileostomies will be assessed as patients with isolated ileal disease via SES-CD.
- 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...
- Stable doses of concomitant medications, as defined in Section 5
- A negative pregnancy test within 2 weeks prior to anticipated commencement of the study drug, in female people of child-bearing age. Men and women of reproductive potential must agree to use an acceptable method of...
- The ability of adult participants who are able to make their own healthcare decisions to provide informed consent or the ability of a legal guardian to provide consent if the participant is a child (less than 18 years...
- A diagnosis of ulcerative colitis or indeterminate colitis.
- Requirement for immediate surgical, endoscopic or radiological intervention for perforation, sepsis, or intra-abdominal or perianal abscess.
- History of colorectal cancer or dysplasia.
- Positive stool test for Clostridium difficile via GDH/EIA two step testing method. PCR only testing will not be accepted. If patient is GDH positive and EIA negative, enrollment will be permitted.
- Current medically significant infection.
- Significant laboratory abnormalities;
- Hb \< 7.0 g/dL, WBC \< 2.5 x 103/mm3, Plt \< 50 x 103/mm3.
- Creatinine ≥ 2x institutional ULN.
- Total bilirubin \> 2.0 mg/dL, ALT \> 2x institutional ULN. Elevated unconjugated bilirubin related to Gilbert's syndrome is allowed.
- Abnormal thyroid function tests.
- Positive serology for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Positive screening test for tuberculosis (TB).
- Treatment with any biologic medication within 4 weeks of first study drug dose (baseline) (see below section on washouts)
- Received another IND within 5 half-lives of that agent baseline.
- Malignancy within the last 5 years, excluding non-melanoma skin cancer.
- Allergy to any component of the study drug.
- Pregnant or lactating women.
- Inability to comply with the study protocol or inability of the subject or the subject's legal guardian to provide informed consent.
- Prior exposure to IL-2.
- Uncontrolled cardiac angina or symptomatic congestive cardiac failure (NYHA Class III or IV).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.