Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen - Cilag International

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

20 Apr 2023 → 26 May 2026

Decision date (initial)

2024-07-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Janssen-Cilag International NV, Belgium

External identifiers

EU CT number

2023-507144-36-00

EudraCT number

2020-005503-40

ClinicalTrials.gov

NCT05083182

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy, Pharmacokinetic

Evaluate PK of ustekinumab and guselkumab in jPsA
Evaluate efficacy of ustekinumab and guselkumab in jPsA

Secondary objectives 4

1. Evaluate PK of ustekinumab and guselkumab in jPsA
2. Evaluate efficacy of ustekinumab and guselkumab in jPsA
3. Evaluate safety of ustekinumab and guselkumab in jPsA
4. Evaluate immunogenicity of ustekinumab and guselkumab in jPsA

Conditions and MedDRA coding

Juvenile psoriatic arthritis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001523-PIP18-03, EMEA-000311-PIP03-11

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. ≥5 to <18 years of age, inclusive.
2. Diagnosis of jPsA by Vancouver inclusion criteria, with exclusion of ERA. Diagnosis made ≥3 months (ie. 90 days) prior to screening. Arthritis plus psoriasis, or arthritis plus ≥2 of the following: dactylitis, nail pits, family history of psoriasis in a first- or second-degree relative, psoriasis-like rash.
3. Active disease in ≥3 joints at screening and at Week 0 (defined as swelling or loss of motion with pain and/or tenderness). Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
4. Have active disease despite previous non-biologic DMARD and/or NSAID therapy: • Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance. • NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance.
5. If previously treated with an anti-TNFα agent (such as adalimumab, etanercept, infliximab, golimumab [SC or IV], certolizumab pegol, or their respective biosimilars) or other biologic agents that are not included in the exclusion criteria, these agents should have been discontinued taking into consideration their elimination half-life, dosing frequency and acceptable clinical practice, before first study intervention administration (see Appendix 7 [Section 10.7] for Table 7 with the required minimal washout period for a specific prior treatment). Refer to Appendix 18 (Section 10.18.1) for country-specific requirements in France for the required minimum washout periods for Anti-TNFα agents.

Exclusion criteria 5

1. Participants with enthesitis-related arthritis (ERA; see definition in Appendix 17 of the study protocol)
2. Taken any disallowed therapies as noted in Section 6.8, Concomitant Therapy within the timeframe specified before the planned first dose of study intervention.
3. If participants were non-responders to previously received IL-23 blockers including guselkumab, tildrakizumab (MK3222) and risankizumab (BI-655066). Prior non-response to an anti-TNFα inhibitor, an IL-17 inhibitor or a Janus kinase (JAK) inhibitor is not an exclusion. Participants who previously discontinued ustekinumab for intolerance or inadequate response may be enrolled into the guselkumab cohort. Patients who previously discontinued guselkumab due to intolerance may be enrolled into the ustekinumab cohort. Participants who previously discontinued tildrakizumab or risankizumab due to intolerance may be enrolled into either cohort.
4. Has other inflammatory disease that might confound the evaluation of benefit from ustekinumab or guselkumab therapy, including but not limited to moderate to severe inflammatory bowel disease, systemic lupus erythematosus, or Lyme disease.
5. Has active uveitis within 12 weeks prior to the first administration of study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Ustekinumab Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 28 by baseline age groups.
2. Ustekinumab ACR Pedi 30 response at Week 24.
3. Guselkumab Steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 28 by baseline age groups.
4. Guselkumab ACR Pedi 30 response at Week 24.

Secondary endpoints 16

1. PK – Ustekinumab Steady-state trough concentrations and population PK model-predicted AUCss over a 12-week dosing interval at Week 52 by baseline age groups
2. PK – Guselkumab Steady-state trough concentrations and population PK model-predicted AUCss over a dosing interval (4 or 8 weeks) at Week 52 by baseline age groups.
3. Efficacy – Ustekinumab ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52.
4. Efficacy – Ustekinumab ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52.
5. Efficacy – Ustekinumab Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24.
6. Efficacy – Ustekinumab Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, and 52.
7. Efficacy – Ustekinumab Change from baseline in PASI score at Week 24 among the participants with ≥3% BSA psoriatic involvement and a PGA psoriasis score of ≥2 (mild) at baseline.
8. Efficacy – Guselkumab ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52.
9. Efficacy – Guselkumab ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52.
10. Efficacy – Guselkumab Time to response measured as time to achieving ACR Pedi 30 from baseline through Week 24.
11. Efficacy – Guselkumab Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12, 16, 24, and 52.
12. Efficacy – Guselkumab Change from baseline in PASI score at Week 24 among the participants with ≥3% BSA psoriatic involvement and a PGA psoriasis score of ≥2 (mild) at baseline.
13. Safety – Ustekinumab The occurrences and type of AEs, SAEs, and reasonably related AEs.
14. Safety –Guselkumab The occurrences and type of AEs, SAEs, and reasonably related AEs.
15. Immunogenicity – Ustekinumab The incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 52 and Week 68.
16. Immunogenicity –Guselkumab The incidence of antibodies to ustekinumab/guselkumab (including peak titers) through Week 52 and Week 68.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen - Cilag International

Sponsor organisation

Janssen - Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Public contact point

Organisation

Janssen - Cilag International

Contact name

CTIS Point of Contact

Third parties 8

Locations

7 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 72 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications