E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
The primary objective of this study is to compare the efficacy (measured by the Psoriasis Area and Severity Index [PASI]) and safety of CHS-1420 and Humira at 12 weeks in subjects with moderate to severe chronic PsO. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare the safety of and response to CHS-1420 and Humira over 24 weeks as well as efficacy/safety of switching from Humira to CHS-1420. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female adult at least 18 years of age;
2. Diagnosis of chronic plaque-type psoriasis at least 6 months prior to Screening;
3. Moderate to severe chronic plaque type psoriasis as defined at Screening by:
1. PASI score of greater than or equal to 12,
2. Physician’s Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale of 0 to 5), and
3. Body surface area affected by chronic plaque-type psoriasis of greater than or equal to 10%;
4. Considered a candidate by the Investigator to start anti-TNF therapy for PsO; |
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E.4 | Principal exclusion criteria |
1. Forms of psoriasis other than chronic PsO (e.g., pustular erythrodermic, guttate psoriasis);
2. Previous receipt of anti-TNF therapies, including infliximab, (Remicade) etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), certolizumab pegol (Cimzia), pentoxyfyliene (Trental);
3. Initiation of a drug that is known to cause or exacerbate psoriasis (including, but not limited to, beta-blockers, lithium, and anti-malarials), within the 6 months prior to Randomization (Week 0/Day 0); those who have been on a stable dose for at least 6 months prior to Randomization without exacerbation of psoriasis may be enrolled and do not need to discontinue these medications;
4. Participation in an investigational drug or device study within the 28 days prior to Randomization (Week 0/Day 0) or a period equal to 5 times the half-life of the investigational agent (whichever is longer);
5. History of alcohol or drug abuse within 2 years prior to Screening;
6. Diagnosis of rheumatic disease, autoimmune disease, connective tissue disease, or immune deficiency disease (e.g., primary Sjögren’s syndrome, systemic lupus erythematosus, demyelinating diseases such as multiple sclerosis); |
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E.5 End points |
E.5.1 | Primary end point(s) |
75% improvement in Psoriasis Area and Severity Index (PASI-75) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 12 relative to baseline, where baseline will be the last assessment prior to beginning study drug (scheduled for Week 0/day 0). |
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E.5.2 | Secondary end point(s) |
1. PASI-75
2. Percentage changes in PASI
3. 50% improvement in Psoriasis Area and Severity Index (PASI-50)
4. 90% improvement in Psoriasis Area and Severity Index (PASI-90)
5. Changes in PSGA of disease activity on a scale from 0 to 5
6. Change in PSGA = 0 to 1, demonstrating clear or almost clear skin |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. at Weeks 2, 4, 6, 8, 10, 16, 20, and 24;
2. from Baseline at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24;
3. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24;
4. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24;
5. from Baseline to Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24 and, as applicable, the Follow-up or ET visit;
6. at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24 and, as applicable, the Follow-up or ET visit; |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
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 |
Armenia |
Belarus |
Bulgaria |
Canada |
Chile |
Croatia |
Estonia |
Georgia |
Hungary |
Israel |
Italy |
Latvia |
Lebanon |
Macedonia, the former Yugoslav Republic of |
Mexico |
Moldova, Republic of |
Poland |
Russian Federation |
Serbia |
Slovakia |
South Africa |
Spain |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |