This study has been transitioned to CTIS with ID 2023-507144-36-00 check the CTIS register for the current data. Primary:Evaluate PK and efficacy of ustekinumab and guselkumab in jPsA. Secondary:Evaluate safety of ustekinumab and guselkumab in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Skin and Connective Tissue Disease
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ustekinumab Primary:
- Steady-state trough concentrations and population PK model-predicted AUCss
over a 12-week dosing interval at Week 28 by baseline age groups.
- ACR Pedi 30 responses at Week 24
Guselkumab Primary:
- 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.
- ACR Pedi 30 responses at Week 24
Secondary outcome
Ustekinumab Secondary:
- Steady-state trough concentrations and population PK model-predicted AUCss
over a 12-week dosing interval at Week 52 by baseline age groups.
- ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52
- ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52
- Time to response measured as time to achieving ACR Pedi 30 from baseline
through Week 24.
- Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12,
16, 24, and 52.
- 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.
- The occurrences and type of AEs, SAEs, and reasonably related AEs.
- The overall incidence of antibodies to ustekinumab (including peak titers)
through Week 68.
Guselkumab Secondary:
- 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.
- ACR Pedi 30 response at Weeks 4, 8, 12, 16, and 52.
- ACR Pedi 50 and 70 responses at Weeks 4, 8, 12, 16, 24, and 52.
- Time to response measured as time to achieving ACR Pedi 30 from baseline
through Week 24.
- Change from baseline in cJADAS 10, JADAS 10, 27, and 71 at Weeks 4, 8, 12,
16, 24, and 52.
- 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.
- The occurrences and type of AEs, SAEs, and reasonably related AEs.
- The overall incidence of antibodies to guselkumab (including peak titers)
through Week 68.
Background summary
Juvenile psoriatic arthritis (JPsA) is a condition that causes joint
inflammation (pain, swelling) and a build-up of cells which form patches of
irritated skin due to an over-reaction of the immune system (the body*s defense
system, which fights infection).
This a Phase 3 study. This means that the study drug has already been tested in
small numbers of healthy volunteers, and in patients with medical conditions,
including JPsA. This study is now testing a larger group of patients with JPsA.
Study objective
This study has been transitioned to CTIS with ID 2023-507144-36-00 check the CTIS register for the current data.
Primary:
Evaluate PK and efficacy of ustekinumab and guselkumab in jPsA.
Secondary:
Evaluate safety of ustekinumab and guselkumab in jPsA
Evaluate immunogenicity of ustekinumab and guselkumab in jPsA
Study design
A global Phase 3, open-label, multicenter study.
Intervention
Subjects will be treated for 52 weeks with study drugs.
For this study we make 2 groups:
• Group 1. The people in this group receive Ustekinumab. They will have 9
visits for health exams and tests. They will take ustekinumab at Week 0, 4, 16,
28, 40 and 52. A total of 6 doses of ustekinumab.
• Group 2. The people in this group receive Guselkumab. Guselkumab can be given
every 8 weeks, as determined by the study doctor. They will have 8 visits for
health exams and tests. They will take guselkumab at Week 0, Week 4 and then
every 8 weeks through week 52.
Subjects and their study doctor will determine which study medicine is best
for use.
All patients in this study will get either ustekinumab or guselkumab. During
the study, subjects and the study staff will know that they are receiving the
study medicine.
The liquid study medicine is given in shot. The needle is put just under the
skin, subcutaneously (SC) in the lower stomach area, front of thigh, back of
upper arms or buttocks
Study burden and risks
Subjects will participate in the study for up to 68 weeks. Subjects will need
to come to the hospital more often than they normally would and they undergo
additional tests. These include physical examination; measurement of vital
signs; urine tests; an eye exam, answer questionnaires and an investigation of
medical history. During the study, participants in Group 1 will receive
ustekinumab at Week 0, 4, 16, 28, 40 and 52. A total of 6 doses of ustekinumab.
Participants in Group 2 will receive guselkumab at Week 0 then every 4 or 8
weeks through week 52.
Risks associated with the study drugs include allergic reactions (including
rash or raised, itchy bumps and serious allergic reactions that could be
life-threatening) and side effects (Infections of the nose, sinuses, airways or
throat, infections such as herpes simplex infections and fungal skin
infections, gastroenteritis, rash, pain at drug injection site, hives, allergic
reactions, decreased white blood cells, hives, swelling and depression).
In conclusion, the risks identified from non-clincal and clinical studies show
an increased clinical benefit is expected from treatment with the study drugs.
Guselkumab and ustekinumab have an overall favorable benefit-risk profile
supporting further continued development of the study drug for patients with
juvenile psoriatic arthritis.
Turnhoutseweg 30
Beerse 2340
NL
Turnhoutseweg 30
Beerse 2340
NL
Listed location countries
Age
Inclusion criteria
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 psioriasis 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. Medically stable on the basis of physical examination, medical history, and
vital signs performed at screening. Any abnormalities must be determination
must be recorded in the participant's source documents and initialed by the
investigator.
5. Medically stable on the basis of clinical laboratory tests performed at
screening. If the results of the serum chemistry panel or hematology are
outside the normal reference ranges, the participant may be included only if
the investigator judges the abnormalities or deviations from normal to not be
clinically significant or to be appropriate and reasonable for the population
under study. This determination must be recorded in the participant's source
documents and initialed by the
investigator.
Exclusion criteria
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. Received an investigational intervention (including investigational
vaccines) or used an invasive investigational medical device within 4 weeks or
5 half-lives (whichever is longer) before the planned first dose of either
study intervention or is currently enrolled in another study using an
investigational intervention or procedure. Receipt of an investigational
vaccine for COVID-19 is not an automatic exclusion criterion; discuss with
medical monitor.
5. Have a history of latent or active granulomatous infection, including TB,
histoplasmosis, or coccidioidomycosis, prior to screening. An exception is made
for participants currently receiving treatment for latent TB with no evidence
of active TB, or who have a history of latent TB and documentation of having
completed appropriate treatment for latent TB prior to the first administration
of either study intervention (Section 5.2, Exclusion criterion 14b of the study
protocol).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EU-CTR | CTIS2023-507144-36-00 |
EudraCT | EUCTR2020-005503-40-NL |
ClinicalTrials.gov | NCT05083182 |
CCMO | NL83457.100.23 |