Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)
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 by itself and the scores were then combined for the final PASI. Final PASI=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 (Wk) 12

Secondary Outcomes (23)

Percentage of Participants Achieving ≥75% Improvement in PASI
Wks 24 and 52
Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab
Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)
Number of Participants With Anti-Ixekizumab Antibodies
Baseline through Wk 52
Percent of Participants Achieving PASI 90% and 100% Improvement
Wks 12, 24 and 52
Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)
Wks 12, 24 and 52
+18 more secondary outcomes

Study Arms (1)

80 mg ixekizumab

EXPERIMENTAL

Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.

Drug: 80 mg ixekizumab

Interventions

80 mg ixekizumabDRUG

Administered SC

Also known as: LY2439821

80 mg ixekizumab

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Men must agree to use a reliable method of birth control during the study
Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Candidates for phototherapy and/or systemic therapy
Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment
At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis
Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis

You may not qualify if:

History of drug-induced psoriasis
Concurrent or recent use of any biologic agent
Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab
Serious disorder or illness other than psoriasis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women
Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis

Contact the study team to confirm eligibility.