E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Plaque Type Psoriasis |
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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 | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 delivered using the SelfDose device for the treatment of subjects with moderate to severe plaque-type psoriasis.
• To assess the safety and tolerability of guselkumab delivered using the SelfDose device in subjects with moderate to severe plaque-type psoriasis.
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E.2.2 | Secondary objectives of the trial |
• To assess the pharmacokinetics (PK) and immunogenicity of guselkumab following subcutaneous administration using the SelfDose device in subjects with moderate to severe plaque-type psoriasis.
• To assess usability and acceptability of the SelfDose device.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Be a man or a woman at least 18 years of age
2.Have a diagnosis of plaque-type psoriasis for at least 6 months before the first administration of study drug.
3.Have a PASI ≥12 at screening and at baseline.
4.Have an IGA ≥3 at screening and at baseline.
5.Have an involved BSA ≥10% at screening and at baseline.
6. Be a candidate for phototherapy or systemic treatment for psoriasis
Please refer to protocol pages 20-22 for all the inclusion criteria
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E.4 | Principal exclusion criteria |
1.Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
2.Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months.
3.Currently has a malignancy or has a history of malignancy within 5 years before screening
4.Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly.
5.Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection, fungal infection, or open, draining, or infected skin wounds or ulcers.
6. Tests positive for hepatitis B virus (HBV) infection or is seropositive for antibodies to hepatitis C virus (HCV) at screening; unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to screening, and have a third negative HCV RNA test result at screening.
7. Has unstable suicidal ideation or suicidal behavior, that may be
defined as an eCSSRS rating at screening of: Suicidal ideation with intention to act, Suicidal ideation with specific plan and intent or a suicide attempt in the last 6 months and is confirmed to be at risk by the investigator based on an evaluation by a mental health professional. The final decision on excluding a subject will be made at the judgment of the investigator.
Please refer to protocol pages 23-26 for all the exclusion criteria
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E.5 End points |
E.5.1 | Primary end point(s) |
Co-primary end points:
• The proportion of subjects who achieve an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal (1) at Week 16.
• The proportion of subjects who achieve a PASI 90 response at Week 16.
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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) |
Major Secondary Endpoints
• The proportion of subjects who achieve an IGA score of cleared (0) at Week 16.
• The proportion of subjects who achieve a PASI 100 response at Week 16.
Other Secondary Endpoints
• The proportion of subjects achieving an IGA score of mild or better (≤2) at Week 16.
• The proportion of subjects who achieve a PASI 75 response and a PASI 50 response at Week 16.
• The percent improvement from baseline in PASI response at Week 16.
• The proportion of subjects with successful, problem-free injections (assessment of usability) at Week 0.
• Self-Injection Assessment Questionnaire (SIAQ) domain scores on the 3 domains with items common to the SIAQ PRE- (Week 0) and POST- (Week 0 and Week 12) self-injection modules.
• SIAQ POST-self-injection domain scores and change from baseline scores for each domain at Weeks 0, 4, 12, and 28.
• The proportion of subjects who had full delivery of the dose confirmed by inspection of the device at Weeks 4 and 12.
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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 | 2 |
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 | No |
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 |
Canada |
Poland |
United States |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |