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Fumaric Acid Esters · 1 trial · 1 indication
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
| Arm | Type | Description |
|---|---|---|
| Ixekizumab | EXPERIMENTAL | 160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24. Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks. |
| Fumaric Acid Esters | ACTIVE_COMPARATOR | Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks. |
| Methotrexate | ACTIVE_COMPARATOR | 7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24. Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks. |
| Name | Type | Description |
|---|---|---|
| Fumaric Acid Esters | DRUG | Administered orally |
| Methotrexate | DRUG | Administered orally |
| Ixekizumab | DRUG | Administered SC |
Inclusion Criteria: * Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline. * Participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis. * Have a (PASI score \>10 or ...
Fumaric acid esters are being developed for the treatment of plaque psoriasis, a chronic inflammatory skin condition. Eli Lilly and Company is studying the therapy in patients with moderate-to-severe plaque psoriasis. The program is in Phase 3 clinical development and remains investigational.
Fumaric acid esters target sphingosine-1-phosphate receptor 1, also known as S1PR1. The drug acts as an agonist at this receptor. S1PR1 is a G protein-coupled receptor involved in lymphocyte trafficking and immune cell regulation, which is relevant to inflammatory skin conditions such as plaque psoriasis.
Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is the developer of fumaric acid esters. The company is running the clinical program evaluating the small molecule therapy in plaque psoriasis.
Fumaric acid esters are in Phase 3 clinical development for plaque psoriasis. The therapy is investigational and has not been approved by the FDA for this indication. One Phase 3 trial has been completed, and no trials are currently listed as active.
The Phase 3 trial NCT02634801 studied fumaric acid esters in participants with moderate-to-severe plaque psoriasis who were naive to systemic treatment. The trial enrolled 162 participants in Germany, was randomized and active-controlled, and has been completed. Participants were 18 years or older.