Approval Probability
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Adjusted LOA
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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 is an investigational small molecule being developed for the treatment of plaque psoriasis. It is currently in Phase 3 clinical development. The drug is being studied in patients with moderate-to-severe plaque psoriasis who have not previously received systemic treatment.
Fumaric Acid Esters is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with plaque psoriasis.
Fumaric Acid Esters is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of plaque psoriasis, and its clinical development program includes a completed Phase 3 trial.
Fumaric Acid Esters has been studied in a Phase 3 clinical trial with the identifier NCT02634801. This trial, titled 'A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment,' enrolled 162 participants in Germany and has been completed.
Fumaric Acid Esters is not the same as Ixekizumab. The clinical trial NCT02634801, which studied Fumaric Acid Esters, also included Ixekizumab as a comparator. Fumaric Acid Esters is a separate investigational drug being developed by Eli Lilly and Company for plaque psoriasis.