Moderate to Severe Genital Psoriasis
Conditions
Brief summary
Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.
Interventions
Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
DRUGPlacebo
Placebo SC injection at Day 1 and Week 4
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines 2. Age ≥ 18 years of age at the time of signing consent 3. Diagnosis of moderate to severe psoriasis of the genital area at Screening and baseline defined as modified sPGA-G score of ≥3. 4. Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline. 5. Presence of psoriasis of the genital area that is inadequately controlled with topical therapy or the subject is intolerant to topical therapy 6. Negative evaluation for TB within 4 weeks before initiating IMP, defined as a negative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests are allowed if they have all of the following: * no history of active tuberculosis (TB) or symptoms of TB, * a posteroanterior chest radiograph (with associated report available at the site) performed within 3 months of Screening with no evidence of active TB ( or of any other pulmonary infectious diseases), * if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care), * if presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to dosing in the study at Visit 2-Week 0. A maximum of 2 QuantiFERON tests of no more than 3 weeks apart are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used
Exclusion criteria
1. Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis. 2. Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition. 3. Active infection or history of infections as follows: * any active infection (bacterial, fungal or viral) for which systemic anti-infectives were used within 28 days prior to first investigational medicinal product (IMP) dose, with the last dose having been received within 7 days of Screening, * a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening, * recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause participation in this study to be detrimental to the subject. 4. Any concurrent medical condition or uncontrolled, clinically significant systemic disease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could jeopardize subject safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline | Week 16 | sPGA-G scale is a 6-point numerical scale that ranges from 0 (clear) to 5 (very severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects, with a baseline score of ≥ 4, who achieve at-least 4-point improvement in weekly average genital psoriasis itch numerical rating scale [GPI-NRS] within the GPSS for subjects | Week 16 | The GPI-NRS is a self-reported measure where participants will assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch. |
| Mean change from baseline in the affected Body Surface Area (BSA) | Week 16 | The BSA will be measured using the palm method where the palm of the subject's hand (including the palmar aspect of the fingers) represents 1 % of the BSA. The affected areas are then calculated by their size compared to the subject's palm. |
| Change from baseline in genital psoriasis symptoms scale [GPSS] total score and individual items scores | Week 16 | The GPSS contains eight items regarding genital psoriasis symptoms. The items separately address itch, pain, discomfort, stinging, burning, redness, scaling, and cracking on an 11-point scale where 0 represents ''no symptom'' and 10 represents ''worst symptom imaginable". Each of the eight items are scored separately; in addition, a total score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms) is reported. |
| Proportion of subjects with psoriasis area and severity index [PASI] 75 response | Week 16 | The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis). |
| Proportion of subjects with PASI 90 response | Week 16 | The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis). |
| Proportion of subjects with PASI 100 response, in subjects with BSA <10% | Week 16 | The PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis). |
Countries
Bulgaria, Georgia, Hungary, Poland, United States
Outcome results
None listed