E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe plaque 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 | 20.0 |
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 |
To determine the efficacy of VTX958 after treatment for 16 weeks in participants with moderate to severe psoriasis. To evaluate the safety and tolerability of VTX958 during the placebo controlled treatment period in participants with moderate to severe psoriasis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of VTX958 on improvement of various measures of psoriasis after treatment for 16 weeks in participants with moderate to severe psoriasis. |
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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 |
Long-Term Extension Period Exploratory objectives: - To examine the efficacy of VTX958 during the LTE period in participants with moderate to severe psoriasis. - To evaluate the safety and tolerability of VTX958 during the LTE period in participants with moderate to severe psoriasis. - To evaluate the plasma concentration of VTX958 during the LTE period in participants with moderate to severe psoriasis.
Open-Label Extension Period Exploratory objectives: - To examine the efficacy of VTX958 during the OLE period in participants with moderate to severe psoriasis. - To evaluate the safety and tolerability of VTX958 during the OLE period in participants with moderate to severe psoriasis. - To evaluate the plasma concentration of VTX958 during the OLE period in participants with moderate to severe psoriasis. |
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E.3 | Principal inclusion criteria |
1. Male or female participant aged 18 years or older. 2. History of primarily plaque psoriasis for at least 6 months prior to the screening visit. 3. Has had stable psoriasis conditions for at least 3 months before screening. 4. Has moderate to severe plaque psoriasis as defined by a PASI score of ≥ 12 and an sPGA score of ≥ 3 at screening and Day 1. 5. Has plaque psoriasis covering ≥ 10% of the total BSA at screening and Day 1. 6. Deemed by the investigator to be eligible for phototherapy or systemic therapy. 7. Females of childbearing potential must agree to use a highly effective contraceptive method from at least 4 weeks prior to Day 1 until at least 4 weeks after the last dose of study product. |
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E.4 | Principal exclusion criteria |
1. Female who is breastfeeding, pregnant, lactating, or who is planning to become pregnant during the study. 2. Has evidence of erythrodermic, pustular, predominantly inverse or guttate psoriasis, or drug-induced psoriasis. 3. History of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments. 4. Participant is known to have immune deficiency or is immunocompromised. 5. Has immune-mediated conditions commonly associated with psoriasis, such as psoriatic arthritis, active uveitis, inflammatory bowel disease, that currently require systemic treatment (including corticosteroids, immunosuppressants, or biologics). Note: Participants with immune-mediated conditions commonly associated with psoriasis that do not require systemic treatment may be included in the study. 6. Has used any topical medication that could affect psoriasis (including corticosteroids, retinoids, vitamin D analogues [such as calcipotriol], JAK inhibitors, or tar) within 2 weeks prior to Day 1. 7. Has used any systemic treatment that could affect psoriasis (including corticosteroids, oral retinoids, immunosuppressive medication, anakinra, methotrexate, cyclosporine, oral JAK inhibitors, or apremilast) within 4 weeks prior to Day 1. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed. 8. Participant has received any ultraviolet B (UVB) phototherapy (including tanning beds) or excimer laser within 4 weeks prior to Day 1. 9. Participant has had psoralen and ultraviolet A (PUVA) treatment within 4 weeks prior to Day 1. 10. Participant has received treatment with an investigational or marketed TYK2 inhibitor. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Proportion of participants achieving PASI-75 at Week 16 • Incidence of AEs and SAEs • Changes in vital signs, clinical laboratory parameters, and ECGs |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Weeks 16 • Screening, Week 0, 1, 2, 4, 8, 12, 16 |
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E.5.2 | Secondary end point(s) |
• Proportion of participants achieving an sPGA score of 0 (clear) or 1 (almost clear) at Week 16 • Change and percent change from baseline in PASI at Week 16 • Proportion of participants achieving PASI-90 at Week 16 • Proportion of participants achieving PASI-100 at Week 16 • Change from baseline in DLQI scores at Week 16 • Change from baseline in BSA at Week 16
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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 | No |
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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 16 |
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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
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 | 11 |