Conditions

Plaque Psoriasis

Keywords

Fumaderm

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24
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).
Week 24

Secondary Outcomes (28)

Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline
Week 24
Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) From Baseline
Week 24
Change From Baseline in PASI Total Score
Baseline, Week 24
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) and ≥2 Point Improvement From Baseline Among Those With sPGA Score ≥3 at Baseline
Week 24
Percentage of Participants Achieving DLQI (0,1)
Week 24
+23 more secondary outcomes

Study Arms (3)

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.

Drug: Ixekizumab

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.

Drug: Fumaric Acid EstersDrug: Ixekizumab

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.

Drug: MethotrexateDrug: Ixekizumab

Interventions

Fumaric Acid EstersDRUG

Administered orally

Fumaric Acid Esters

MethotrexateDRUG

Administered orally

Methotrexate

IxekizumabDRUG

Administered SC

Also known as: LY2439821

Fumaric Acid EstersIxekizumabMethotrexate

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 BSA \>10) and DLQI \>10 at screening and at baseline.

You may not qualify if:

Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
Have received systemic nonbiologic psoriasis therapy.
Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy.
Have any condition or contraindication as addressed in the local labeling for MTX or FAE.
Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening.
Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer.
Have had a serious infection or are immunocompromised.
At screening, participants with significant, present, or early liver disease, e.g., explained by alcohol consumption or hepatic insufficiency.

Contact the study team to confirm eligibility.