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Crohn DiseasePhase 1/2NCT04263831

Low Dose IL-2 for the Treatment of Crohn's Disease

A Phase 1/2 study testing Interleukin-2 (aldesleukin). in people with Crohn Disease, run by Boston Children's Hospital at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 80 years
Conditions the study is for
Crohn Disease
What is being tested?
Interleukin-2 (aldesleukin).
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
11 Mar 2021to 30 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 subset of patients with Ileostomies or colostomies will be permitted.
  • Adult subjects with moderate-to-severe CD (CDAI score 220-450)
  • 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
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  • 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.

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Delaney Sartwell contact

617-525-7322

dsartwell@bwh.harvard.edu

Richelle L Bearup, MPH contact

617-919-4592

richelle.bearup@childrens.harvard.edu

United States3 sites, 3 recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Richelle L Bearup, MPH, 617-919-4592, richelle.bearup@childrens.harvard.edu

    Daniel Ironson, 617-919-4592, Daniel.ironson@childrens.harvard.edu

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Delaney Sartwell, 617-525-7322, dsartwell@bwh.harvard.edu

    Jessica Allegretti, MD, MPH

    Recruiting

  • Mount Sinai

    New York, New York, 10029

    Sari Feldman, 212-824-7669, sari.feldman@mssm.edu

    Jean Fred Colombel, MD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Despite recent advances in treatment, a significant proportion of patients with Crohn's disease have suboptimal responses to medical therapy, leaving an urgent need to identify new therapies. One promising new approach to treat IBD is through the manipulation of regulatory T cells (Tregs). Tregs are an immune modulating subset of CD4+ lymphocytes that antagonize the activation and effector function of multiple immune cell types and promote tolerance to self-antigens. Adoptively transferred Tregs are effective in murine models of IBD. An alternative approach to disease management through Treg manipulation is to increase Treg numbers in vivo. Interleukin-2 (IL-2, Proleukin®) is a T cell growth factor. IL-2 is currently licensed for the treatment of metastatic renal cell carcinoma and metastatic melanoma. At low doses, IL-2 promotes the selective activation and expansion of Tregs in humans. Tregs constitutively express CD25, a component of the high-affinity IL-2R, while CD25 is only transiently expressed by activated conventional T effector cells. Low-dose (LD) IL-2 selectively expands Tregs in humans and is safe in chronic GvHD and other phase 1 and 2 clinical trials.

This is a phase 1b/2a clinical trial to assess the safety and the efficacy of LD SC IL-2 for the treatment of CD utilizing daily sc LD IL-2 for 8 weeks in CD patients to determine the maximum effective dose (MED) and safety profile, and to assess a signal of efficacy. We aim to determine in CD patients whether sc LD IL-2 modulates peripheral blood and lamina propria Tregs in vivo and correlates with clinical outcome. We will perform deep immunophenotyping in CD patients treated with LD IL-2 and comprehensively assess the effects of LD IL-2 on CD4+ Tregs and other immune cells in both peripheral and mucosal compartments, and correlate changes in immune phenotype with clinical outcome. Overall this trial is designed to determine the MED and safety profile of LD IL-2 in CD, to obtain a signal of efficacy, and to assess mechanistic underpinnings.

Conditions
Crohn Disease
Being tested
Interleukin-2 (aldesleukin).
Keywords
Inflammatory bowel disease, Interleukin 2, Regulatory T Cells
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interleukin-2 (aldesleukin).Drug

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

Study groups in NCT04263831
Study groupRoleWhat they receive
Interleukin-2ExperimentalStudy 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.
Receives: Drug: Interleukin-2 (aldesleukin).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

  2. Maximum effective dose

    Identification of the dose cohort at which the MED occurs.

    Measured: 8 weeks

Secondary outcomes (2)

  1. Clinical Response

    This is a composite endpoint. CDAI scores will be used to assess clinical activity. Moderate to severe CD, denoted by a CDAI score 220-450, is an inclusion criterion.

    Definition of Clinical Response. CDAI-100 response (≥100-point decrease in the CDAI score) at week 8 Composite Outcome: Clinical response and at least a 50% decrease in fecal calprotectin or CRP

    Measured: 8 weeks

  2. Immunological Response

    Enumeration of the number of subjects with a change in the absolute number of immune cells in the peripheral blood and lamina propria of subjects during the 8 weeks of treatment, and during the 4 weeks following cessation of treatment.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start11 Mar 2021
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04263831
Sponsor's protocol ID
IRB-P00032653
Other IDs
R01DK126448
Status last verified
Jul 2026
First submitted
7 Feb 2020
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22129252

  • 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.

    PubMed 23552371

  • 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.

    PubMed 22129253

  • 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.

    PubMed 3317057

  • 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.

    PubMed 16339095

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Interleukin-2 (aldesleukin). in people with Crohn Disease, run by Boston Children's Hospital at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Delaney Sartwell (617-525-7322, dsartwell@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with serious and non-serious adverse events. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04263831, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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