Crohn's Disease: Pharmacokinetics, Efficacy, and Safety of Risankizumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease

Phase 1

Recruiting

• Conditions: Crohn's disease; MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]; Therapeutic area: Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2022-502050-14-00
• Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-07
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Subjects and/or their legally authorized representative must voluntarily sign and date an informed consent (and assent for minors as required by applicable regulation), approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures. In Japan, a subject's parent or legal guardian must be willing to give written informed consent. In China, the legal guardian must be willing to give written informed consent; subjects aged 8 to < 18 years must also be willing to give written informed consent., Weight at the time of Screening and Baseline must be = 10 kg., Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: • Serum ALT = 2 × ULN; • Serum AST = 2 × ULN; • Serum total bilirubin < 2 mg/dL; except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome; • Total WBC count = 3,000/µL; • ANC = 1,500/µL; • Platelet count = 100,000/µL; • Hemoglobin = 8 g/dL (80 g/L)., Confirmed diagnosis of CD at least 3 months (90 days) prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available., Must have moderately to severely active CD, as defined by the PCDAI score > 30 assessed at Baseline., Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of = 6 for ileocolonic or colonic disease (or SES-CD of = 4 for isolated ileal disease). All eligible scores exclude the presence of narrowing component and are confirmed by a central reader., Demonstrated intolerance or IR to one or more of the following categories of drugs: aminosalicylates (this drug class is not sufficient for eligibiliy for subjects in FR, IT, NL, Es and SE), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies., Subject is judged to be in good general health, as determined by the investigator based upon the results of a medical history, physical examination, laboratory profile, and a 12-lead ECG performed during the Screening period., Subjects with CD involving the colon of > 9 years' duration must have documented evidence of a negative surveillance colonoscopy for dysplasia within 24 months before Baseline., Females of child-bearing potential must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at Baseline prior to the first dose of study drug. • Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test =3 days later to document continued lack of a positive result (unless prohibited by local requirements). • Urine pregnancy test: Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive., Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, from Baseline through at least 140 days (20 weeks or as guided by the local risankizumab label [if approved], whichever is longer) after the last dose of study drug (local practices may require 2 methods of birth control; refer to Section 5.2 for more details on change in childbearing potential of female subjects and contraception). Female subjects of no

Exclusion Criteria

Employees of the sponsor and/or study sites and their immediate family members may not be enrolled in this study., Female subjects may not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 140 days (20 weeks or as guided by the local risankizumab label [if approved], whichever is longer) after the last dose of study drug., Subject must not have received any replicating live viral or bacterial vaccine within 4 weeks prior to the first dose of study drug or expect the need for live vaccination during study participation including at least 140 days (20 weeks or as guided by the local risankizumab label [if approved], whichever is longer) after the last dose of study drug., Subjects are excluded if: (a) Subject on CD-related antibiotics who has not been on stable doses for greater than, or discontinued within, 14 days prior to Baseline. (b) Subject on oral aminosalicylates who has not been on stable doses for greater than, or discontinued within, at least 14 days prior to Baseline. (c) Subject taking oral corticosteroids: • Budesonide > 9 mg/day • Prednisone or equivalent > 20 mg/day, or • Has not been on the current course for = 14 days prior to Baseline and on a stable dose for = 7 days prior to Baseline. (d) Subject on IMMs (AZA, 6-MP, MTX) who: • Has not been on the current course for = 42 days prior to Baseline • Has not been on a stable dose for = 28 days prior to Baseline, or • Has stopped IMM = 28 days prior to Baseline, For medications and treatments taken during the Screening Period, subjects are excluded if: (a) Subjects on growth hormone who have not been on a stable dose for at least 12 weeks prior to Baseline. Subjects must consent to remain on a stable dose through the duration of the study. (b) Subject who received IV anti-infectives within 28 days prior to Baseline visit or oral/intramuscular anti-infectives (non-CD-related) within 14 days prior to the Baseline visit. This does not apply to TB prophylaxis. (c) Subject who received total parenteral nutrition within 28 days prior to Baseline. (d) If receiving exclusive enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to Baseline. (e) Subject who received oral cyclosporine, oral tacrolimus, mycophenolate mofetil, or thalidomide (for subjects in China) within 28 days prior to Baseline. (f) Subject who received fecal microbial transplantation within 28 days prior to Baseline., The following prior medications and treatments are not allowed: (a) Subject who received any: • Biologic agent: infliximab and/or adalimumab, including biosimilars, within 2 half-lives (4 weeks) prior to Baseline. Or • Any investigational biologic or other agent or procedure within 30 days or 5 half-lives prior to Baseline, whichever is longer, or currently enrolled in another interventional clinical study. (b) Subject with prior exposure to p19 inhibitors (e.g., risankizumab and mirikizumab). (c) Subject has been taking combination of oral budesonide and/or oral prednisone (or equivalent), with the exception of inhalers, within 14 days prior to Screening or during the Screening period. (d) Subject who received IV/intramuscular corticosteroids during the Screening period. (e) Subject who received therapeutic enema or suppository, other than required for endoscopy during the Screening period. (f) Subject who received apheresis (e.g., Adacolumn apheresis) = 60 days prior to Screening or during the Screening period. (g) Subject

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified