Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants with Moderately to Severely Active Crohn’s Disease

A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease - MACARONI-23

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006282-37-NO

Enrollment

120

Registered

2022-11-17

Start date

2023-08-16

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Guselkumab Product Code: CNTO1959 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Guselkumab Current Sponsor code: CNTO1959 Concentration unit: mg/ml milligram(s)/millili

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 2 to 30). 5. Have endoscopy with evidence of active CD defined as SES-CD score =6 (or =4 for participants with isolated ileal disease) within 4 weeks of receiving study intervention at Week 0. Please refer to the protocol for more exclusion criteria Are the trial subjects under 18? yes Number of subjects for this age range: 120 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

Exclusion criteria: 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, that could preclude the use of the PCDAI to assess response to therapy or would possibly confound the ability to assess the effect of the treatment. Of note, surgical procedures related to fistula treatment are not necessarily exclusionary; discuss with medical monitor. 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 Week 0, or 8 weeks prior to Week 0 for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. 3. Has had any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline. 4. Presence of a stoma, ileoanal pouch, or ostomy. 5. Has high grade dysplasia, history of or current evidence of polypoid or non-polypoid dysplasia, or any adenoma that has not been removed. Please refer to the protocol for more exclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of guselkumab in pediatric participants with CD at the end of maintenance therapy among participants who were in clinical response to guselkumab at Week 12;Secondary Objective: 1. To evaluate the clinical efficacy of guselkumab in pediatric participants with CD 2. To evaluate the efficacy of treatment with guselkumab in clinical remission by PRO at Week 12 and/or Week 52 3. To evaluate the PK and immunogenicity of guselkumab in pediatric participants with CD 4. To assess the impact of guselkumab therapy on growth 5. To evaluate the safety of guselkumab in pediatric participants with CD 6. To evaluate the efficacy of treatment with guselkumab in participants who are assigned at Week 12 to q4w maintenance therapy and do not receive non investigational product (IP) rescue therapy;Primary end point(s): 1. Clinical remission (defined as PCDAI score =10) 2. Endoscopic response (=50% reduction from SES-CD score at baseline) ;Timepoint(s) of evaluation of this end point: 1. At Week 52 2. At Week 52	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of guselkumab in pediatric participants with CD at the end of maintenance therapy among participants who were in clinical response to guselkumab at Week 12;Secondary Objective: 1. To evaluate the clinical efficacy of guselkumab in pediatric participants with CD 2. To evaluate the efficacy of treatment with guselkumab in clinical remission by PRO at Week 12 and/or Week 52 3. To evaluate the PK and immunogenicity of guselkumab in pediatric participants with CD 4. To assess the impact of guselkumab therapy on growth 5. To evaluate the safety of guselkumab in pediatric participants with CD 6. To evaluate the efficacy of treatment with guselkumab in participants who are assigned at Week 12 to q4w maintenance therapy and do not receive non investigational product (IP) rescue therapy;Primary end point(s): 1. Clinical remission (defined as PCDAI score =10) 2. Endoscopic response (=50% reduction from SES-CD score at baseline) ;Timepoint(s) of evaluation of this end point: 1. At Week 52 2. At Week 52

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Secondary

Measure	Time frame
Secondary end point(s): 1. Clinical response (decrease from baseline/LOR reference in the PCDAI score =12.5; total score =30) 2. Clinical response (PCDAI) 3. Clinical remission (PCDAI) 4. Endoscopic response (SES-CD) 5. Endoscopic remission (SES-CD) 6.Corticosteroid-free clinical remission (defined as PCDAI score =10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52) 7. Sustained clinical remission (defined as PCDAI =10) 8. Serum guselkumab concentration during induction 9. Serum guselkumab concentration during maintenance (at least Ctrough) 10. Change from baseline in: -Weight -Weight percentiles and z-scores -Height -Height percentiles and z-scores -Height Velocity 11. AEs, including SAEs ;Timepoint(s) of evaluation of this end point: 1. At Week 12 2. At Week 52 3. At Week 12 4. At Week 12 5. At Week 52 6. At Week 52 7. At Weeks 12, 24, and 52 8. From Week 0 through Week 12 9. N/A 10. At Week 12, 24 and 52 11. N/A	—

Measure

Time frame

Secondary end point(s): 1. Clinical response (decrease from baseline/LOR reference in the PCDAI score =12.5; total score =30) 2. Clinical response (PCDAI) 3. Clinical remission (PCDAI) 4. Endoscopic response (SES-CD) 5. Endoscopic remission (SES-CD) 6.Corticosteroid-free clinical remission (defined as PCDAI score =10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52) 7. Sustained clinical remission (defined as PCDAI =10) 8. Serum guselkumab concentration during induction 9. Serum guselkumab concentration during maintenance (at least Ctrough) 10. Change from baseline in: -Weight -Weight percentiles and z-scores -Height -Height percentiles and z-scores -Height Velocity 11. AEs, including SAEs ;Timepoint(s) of evaluation of this end point: 1. At Week 12 2. At Week 52 3. At Week 12 4. At Week 12 5. At Week 52 6. At Week 52 7. At Weeks 12, 24, and 52 8. From Week 0 through Week 12 9. N/A 10. At Week 12, 24 and 52 11. N/A

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Countries

Austria, Belgium, Canada, Czechia, France, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, United Kingdom, United States

Contacts

Public ContactClinical Registry Group

Janssen Biologics B.V.

ClinicalTrialsEU@its.jnj.com+31 71 5242166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026