E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis Axial Disease |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of guselkumab treatment in participants with active PsA axial disease by assessing reduction in axial symptoms. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of guselkumab on additional measures of axial symptoms, reduction in axial inflammation, and other signs and symptoms of PsA, psoriasis, and participant well-being. - To evaluate the safety of guselkumab in participants with active PsA. - To evaluate the pharmacokinetics and immunogenicity of guselkumab in participants with active PsA.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Initial Clinical Protocol, 14 April 2021, version 1.0. An MRI of hands/feet may be collected from participants at certain sites who consent to this optional substudy component of the study. |
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E.3 | Principal inclusion criteria |
- Be at least 18 years of age. - Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening. - Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and C-reactive protein ≥0.3 mg/dL at screening from the central laboratory. - Have a BASDAI score of at least 4. - Have magnetic resonance imaging-confirmed PsA axial disease (positive MRI spine and/or SI joints, shown by a SPARCC score of ≥3 in either the spine or the sacroiliac joints). - Have a spinal pain score of at least 4.
For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol
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E.4 | Principal exclusion criteria |
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic-axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease. - Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment. - Has ever received a Janus kinase inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor. - Has received any systemic immunosuppressants within 4 weeks of the first administration of study intervention. - Has received apremilast within 4 weeks prior to the first administration of study intervention. - Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.
For the complete overview of the exclusion criteria, please refer to section 5.2 of the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in BASDAI at Week 24. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change from baseline in ASDAS-CRP at Week 24 - Change from baseline in Disease Activity Index for Psoriatic Arthritis at Week 24 - Change from baseline in Health Assessment Questionnaire – Disability Index at Week 24 - Proportion of participants with investigator’s global assessment 0/1 response at Week 24 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 at baseline. - Change from baseline in Spondyloarthritis Research Consortium of Canada score for MRI sacroiliac joints at Week 24 - Proportion of participants who achieve a ≥50% improvement from baseline in BASDAI score at Week 24 - Proportion of participants who achieve ASDAS clinically important improvement at Week 24 - Proportion of participants who achieve ASAS 40 response at Week 24 - Proportion of participants who achieve ASDAS major improvement at Week 24 - Change from baseline in SPARCC score for MRI spine at Week 24 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Immunogenicity and Biomarker assessments |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 95 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Hong Kong |
Israel |
Malaysia |
Puerto Rico |
Russian Federation |
Taiwan |
Turkey |
Ukraine |
United States |
Denmark |
France |
Germany |
Hungary |
Poland |
Portugal |
Spain |
United Kingdom |
Czechia |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |