Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sun Pharmaceutical Industries Limited | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
25 adult subjects with moderate to severe plaque psoriasis will receive Ilumya 100mg subcutaneously at weeks 0, 4 and 16.
At week 16, patients with remaining BSA ˃3% will be given HALOG ointment 0.1% to apply BID for 4 weeks. Patients who have ≤3% BSA at week 16 will remain on Ilumya monotherapy.
Patients will continue to be evaluated at weeks 20 and 24.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ilumya | Experimental | Ilumya 100mg subcutaneous at weeks 0, 4 and 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilumya Injectable Product | Drug | IL-23 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body surface area | evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1% | 16 weeks |
Not provided
Not provided
Inclusion Criteria:
Male or female adult ≥ 18 years of age;
Diagnosis of moderate-to-severe chronic plaque-type psoriasis as defined by
Must be a candidate for phototherapy and/or systemic therapy
Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jerry Bagel, MD | Contact | 6094434500 | dreamacres1@aol.com | |
| Elise Nelson | Contact | 6094434500 | enelson@windsordermatology.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psoriasis Treatment Center of Central New Jersey | Recruiting | East Windsor | New Jersey | 08520 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2024 | Apr 10, 2024 | 1 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
open label
Not provided
Not provided
Not provided
Not provided