A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease

Phase 1

Conditions: Moderately to severely active Crohn's disease
MedDRA version: 19.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2016-001956-22-FR

Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Be a pediatric subject 2 to <18 years old in the US, 6 to <18 years old elsewhere, of either gender.
2. Have CD or fistulizing CD of at least 3 months duration, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.
3. Must have moderately to severely active CD
4. Prior or current medication for CD must include at least 1 of the following:
a. Current treatment with at least 1 of the following therapies: oral corticosteroids, the
immunomodulators AZA, 6-MP, or MTX, or currently have or have had a history of corticosteroid dependency
OR
b. Have a history of failure to respond to, or tolerate, at least 1 of the following therapies:
oral or IV corticosteroids, the immunomodulators AZA, 6-MP, or MTX.
OR
c. Have required more than 3 courses of oral or IV corticosteroids in the past year.
5. Must meet the following requirements for current concomitant medications for CD criteria:
- Corticosteroids
- 5-aminosalyscilic (5-ASA) compounds
- Antibiotics
- Immunomodulators
6. If receiving total parenteral or enteral nutrition, must have been receiving for at least 2 weeks prior to baseline
7. Before randomization, a girl must be either:
- Not of childbearing potential
- Of childbearing potential
8. All girls of childbearing potential must have a negative highly sensitive serum pregnancy test (ß-human chorionic gonadotropin [ß-hCG]) at screening.
9. A girl must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction
during the study and for 6 months after receiving the last dose of study agent.
10. Have negative stool results for enteric pathogens. Stool studies must include a stool culture
and Clostridium difficile toxin assay. These must have been performed during screening or the current episode of disease exacerbation as long as the stool studies were performed within 4 months prior to the first administration of study agent.

Please refer to pages 23-26 of the protocol for the complete list of the the inclusion criteria

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Disease Characteristics
1. Has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the PCDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses
are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified.
3. Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months prior to baseline.
4. Has a draining (ie, functioning) stoma or ostomy.

Concomitant or Previous Medical Therapies Received
5. Has received any of the following prescribed medications or therapies within the specified
period:
a. IV corticosteroids <3 weeks prior to baseline.
b. Natalizumab within 12 months of baseline.
c. Anti-TNF biologic agents (eg, monoclonal antibody therapies) or other agents intended to suppress or eliminate TNF <8weeks prior to baseline.
d. Vedolizumab <16 weeks prior to baseline.
e. Other oral immunomodulatory agents (eg, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil) within 8 weeks prior to baseline.
f. Nonautologous stem cell therapy (eg, Prochymal), efalizumab or biologic agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) within 12 months of baseline, or continue to manifest depletion of B or T cells more than 12 months after completion of therapy with lymphocyte depleting agents.
g. Have used any investigational drug within 4 weeks prior to baseline or within 5 half lives of the investigational agent, whichever is longer.
h. Have used apheresis within 2 weeks prior to baseline.
i. Other immunosuppressant biologic agents <12 weeks or within 5 half-lives of agent prior to baseline, whichever is longer.
6. Has previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab, briakinumab (ABT-874), or guselkumab.
Infections or Predisposition to Infections
7. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or
coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening.
8. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, an open
draining, or infected skin wound, or an ulcer.
9. Have immune deficiency syndrome
10. Have a known history of infection with human immunodeficiency virus (HIV).
11. Has evidence of herpes zoster infection =8 weeks prior to baseline.
12. Have a known history of hepatitis C infection.
13. Subjects must undergo screening for hepatitis B virus
14. Have had a Bacille Calmette-Guerin vaccination within 12 months of screening.
15. Have received, or are expected to receive, any live virus or bacterial vaccination less than 2 weeks prior to the first administration of study agent, during the study, or within 15 weeks after the last administration of stu

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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