NCT04263831

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
20mo left

Started Mar 2021

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Mar 2021Dec 2027

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 11, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

February 7, 2020

Last Update Submit

January 31, 2026

Conditions

Crohn Disease

Keywords

Inflammatory bowel diseaseInterleukin 2Regulatory T Cells

Outcome Measures

Primary Outcomes (2)

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

    Enumeration of the serious and non-serious adverse events seen in the study. Enumeration of any dose limiting toxicity seen in the study.

    8 weeks

  • Maximum effective dose

    Identification of the dose cohort at which the MED occurs.

    8 weeks

Secondary Outcomes (2)

  • Clinical Response

    8 weeks

  • Immunological Response

    12 weeks

Study Arms (1)

Interleukin-2

EXPERIMENTAL

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.

Drug: Interleukin-2 (aldesleukin).

Interventions

Interleukin-2 (aldesleukin).DRUG

Description of intervention is covered in "Arm", above.

Interleukin-2

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 12-80 years. Maximum age limit for subjects 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 subjects 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 per day.
  • 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, 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.
  • 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 subjects of child-bearing age. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
  • 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 of age) or has mild intellectual disability and cannot consent for him or herself. In the event that a legal guardian provides consent, the study participant must be able to demonstrate an understanding of the study at his or her comprehension level and must have the ability to give verbal assent. If the legal guardian is court appointed, then the legal guardian must be able to provide documentation of court appointed guardianship.

You may not qualify 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 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (5)

  • Koreth J, Matsuoka K, Kim HT, McDonough SM, Bindra B, Alyea EP 3rd, Armand P, Cutler C, Ho VT, Treister NS, Bienfang DC, Prasad S, Tzachanis D, Joyce RM, Avigan DE, Antin JH, Ritz J, Soiffer RJ. Interleukin-2 and regulatory T cells in graft-versus-host disease. N Engl J Med. 2011 Dec 1;365(22):2055-66. doi: 10.1056/NEJMoa1108188.

    PMID: 22129252BACKGROUND

  • Matsuoka K, Koreth J, Kim HT, Bascug G, McDonough S, Kawano Y, Murase K, Cutler C, Ho VT, Alyea EP, Armand P, Blazar BR, Antin JH, Soiffer RJ, Ritz J. Low-dose interleukin-2 therapy restores regulatory T cell homeostasis in patients with chronic graft-versus-host disease. Sci Transl Med. 2013 Apr 3;5(179):179ra43. doi: 10.1126/scitranslmed.3005265.

    PMID: 23552371BACKGROUND

  • Saadoun D, Rosenzwajg M, Joly F, Six A, Carrat F, Thibault V, Sene D, Cacoub P, Klatzmann D. Regulatory T-cell responses to low-dose interleukin-2 in HCV-induced vasculitis. N Engl J Med. 2011 Dec 1;365(22):2067-77. doi: 10.1056/NEJMoa1105143.

    PMID: 22129253BACKGROUND

  • Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.

    PMID: 3317057BACKGROUND

  • Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.

    PMID: 16339095BACKGROUND

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Scott Snapper, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Jessica Allegretti, MD, MPH

    Brigham and Women's Hosptial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidy Cabral

CONTACT

617-525-7322hjcabral@bwh.harvard.edu

Richelle L Bearup, MPH

CONTACT

617-919-4592richelle.bearup@childrens.harvard.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Gastroenterology

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

March 11, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)