PsoriasisPhase 3UNCOVER-1NCT01474512

A Phase 3 Study in Participants With Moderate to Severe Psoriasis

A Phase 3 study testing 80 mg Ixekizumab Dosing Regimens 1, 2, and 3 in people with Psoriasis, run by Eli Lilly and Company at 104 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,296 participants
Where: 104 sitesin 11 countries
Study dates: 16 Nov 2011to 20 Sep 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
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 randomization
Candidate for phototherapy and/or systemic therapy
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

Who cannot join

Pustular, erythrodermic, and/or guttate forms of psoriasis
History of drug-induced psoriasis
Clinically significant flare of psoriasis during the 12 weeks prior to randomization
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 randomization
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study

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Have participated in any study with interleukin (IL)-17 antagonists, including LY2439821
Serious disorder or illness other than plaque psoriasis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women.

Trial locations and contacts

104 sites in 11 countries.

Country

City, postcode or hospital

104 sites in 11 countries

United States34 sites

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Anaheim, California, 92801
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Arlington Heights, Illinois, 60005
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Atlanta, Georgia, 30327
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Bakersfield, California, 93309
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Baton Rouge, Louisiana, 70809
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Bellingham, Washington, 98225
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Birmingham, Alabama, 35233
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Chicago, Illinois, 60611
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Cleveland, Ohio, 44106
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Evansville, Indiana, 47714
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Fremont, California, 94538
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Indianapolis, Indiana, 46256
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Jacksonville, Florida, 32216
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Johnston, Rhode Island, 02919
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Knoxville, Tennessee, 37922
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Miami, Florida, 33175
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Miramar, Florida, 33027
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New Haven, Connecticut, 06511
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New York, New York, 10021
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Ocala, Florida, 34471
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Ormond Beach, Florida, 32174
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Owensboro, Kentucky, 42303
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Pinellas Park, Florida, 33781
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Portland, Oregon, 97223
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Raleigh, North Carolina, 27612
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Rochester, New York, 14623
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Salt Lake City, Utah, 84132
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Seattle, Washington, 98101
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South Bend, Indiana, 46617
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St Louis, Missouri, 63117
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Tampa, Florida, 33624
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The Bronx, New York, 10467
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Troy, Michigan, 48084
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West Palm Beach, Florida, 33409

Other trials in United States

Germany13 sites

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Berlin, 13125
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Cologne, 50937
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Darmstadt, 64283
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Frankfurt, 60596
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Hamburg, 22143
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Hanau, 63450
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Hanover, 30449
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Kiel, 24105
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Mahlow, 39110
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Mainz, 55131
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Münster, 48149
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Quedlinburg, 06484
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Wuppertal, 42275

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Canada12 sites

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Ajax, Ontario, L1S7K8
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Barrie, Ontario, L4M6L2
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Halifax, Nova Scotia, B5H1Z4
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London, Ontario, N6A 3H7
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Moncton, New Brunswick, E1C8X3
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Montreal, Quebec, H3Z 2S6
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Newmarket, Ontario, L3Y6P5
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Richmond Hill, Ontario, L4B 1A5
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Surrey, British Columbia, V3R 6A7
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Waterloo, Ontario, N2J 1C4
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Windsor, Ontario, N8W 1E6
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Winnipeg, Manitoba, R3C 1R4

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Japan8 sites

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Aichi, 467-0001
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Fukuoka, 814-0180
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Kochi, 783-8505
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Kyoto, 602-0841
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Shiga, 520-2192
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Shizuoka, 431-3125
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Tochigi, 329- 0498
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Tokyo, 169-0073

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Poland8 sites

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Bialystok, 15-017
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Elblag, 82-300
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Krakow, 30-510
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Lodz, 90-265
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Lublin, 20-081
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Szczecin, 70-111
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Torun, 87-100
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Warsaw, 04-749

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Australia7 sites

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Adelaide, South Australia, 5000
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Benowa, Queensland, 4217
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Carlton, Victoria, 3053
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Fremantle, Western Australia, 6160
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Kogarah, New South Wales, 2217
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Parkville, Victoria, 3050
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Woolloogabba, Queensland, 4120

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Hungary6 sites

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Budapest, 1036
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Debrecen, 4032
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Miskolc, 3529
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Szeged, H-6720
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Szolnok, H-5000
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Szombathely, H-9700

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United Kingdom5 sites

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Dundee, Scotland, DD1 9SY
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Lanarkshire, ML6 0JS
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Nuneaton, Warwickshire, CV10 7BL
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Salford, Manchester, M6 8HD
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Scunthorpe, North Lincolnshire, DN15 7BH

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Italy4 sites

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Bergamo, 24128
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Bologna, 40100
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Padova, 35128
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Pisa, 56126

Other trials in Italy

Romania4 sites

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Baia Mare, 430193
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Bucharest, 21155
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Craiova, 200642
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Iași, 700125

Other trials in Romania

Denmark3 sites

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Aarhus, 8000
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Copenhagen, 2400
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Hellerup, 2900

Other trials in Denmark

About this study

Official title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis

This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.

Conditions: Psoriasis
Being tested: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3, Placebo
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

80 mg Ixekizumab Dosing Regimens 1, 2, and 3Drug
Also called LY2439821
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT01474512
Study group	Role	What they receive
80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)	Experimental	Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 [every 2 weeks (Q2W)] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 [every 4 weeks (Q4W)] or Dosing Regimen 3 [every 12 weeks Q12W)]. Receives: Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3
80 mg Ixekizumab Dosing Regimen 2 (Q4W)	Experimental	Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W). Receives: Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3
80 mg Ixekizumab Dosing Regimen 3 (Q12W)	Experimental	Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W. Receives: Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3
Placebo	Placebo comparator	Administered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Measured: Week 12
Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (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 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). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Measured: Week 12

Secondary outcomes (15)

Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
Measured: Week 12
Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps 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 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). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.
Measured: Week 12
Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
Measured: Week 60
Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Measured: Baseline, Week 12
Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score
DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM).
Measured: Baseline, Week 12
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.
Measured: Baseline, Week 12
Percent of Body Surface Area (BSA) Involvement of Ps
BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.
Measured: Week 12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.
Measured: Baseline, Week 12
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO)
WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).
Measured: Baseline, Week 12
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)
QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.
Measured: Baseline, Week 12
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)
The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. It comprises 36-items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.
Measured: Baseline, Week 12
Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)
The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM.
Measured: Baseline, Week 12
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement
The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.
Measured: Week 12
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
Measured: Weeks 12: Day 84 and Week 24: Day 168
Percentage of Participants With Anti-ixekizumab Antibodies
Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Measured: Baseline through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 201120 Sep 2018

First posted18 Nov 2011 (estimated)
Study start16 Nov 2011
Primary completion24 Jun 2014
Study completion20 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,296 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01474512
Sponsor's protocol ID: 12972
Other IDs: I1F-MC-RHAZ
Acronym: UNCOVER-1
Status last verified: 18 Jan 2019
First submitted: 15 Nov 2011
Last updated: 3 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Egeberg A, Hawkes JE, Somani N, Burge R, See K, Gallo G, McKean-Matthews M, Gooderham M, Han G, Armstrong A. Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60. Dermatol Ther (Heidelb). 2024 Apr;14(4):1007-1018. doi: 10.1007/s13555-024-01147-7. Epub 2024 Apr 22.
PubMed 38647975
Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
PubMed 37400681
Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
PubMed 35279805
Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.
PubMed 32200512
Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.
PubMed 27299809
Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.
PubMed 26953848

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Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT01474512
Acronym / sponsor ID: UNCOVER-1 / 12972
Conditions: Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,296 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 16 Nov 2011 (actual)
Primary completion: 24 Jun 2014 (actual)
Study completion: 20 Sep 2018 (actual)
First posted: 18 Nov 2011 (estimated)
Results: Posted 27 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)	Experimental	Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 [every 2 weeks (Q2W)] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 [every 4 weeks (Q4W)] or Dosing Regimen 3 [every 12 weeks Q12W)].
80 mg Ixekizumab Dosing Regimen 2 (Q4W)	Experimental	Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W).
80 mg Ixekizumab Dosing Regimen 3 (Q12W)	Experimental	Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W.
Placebo	Placebo comparator	Drug: PlaceboAdministered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
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 randomization
Candidate for phototherapy and/or systemic therapy
Men must agree to use a reliable method of birth control during the study

Key exclusion criteria (10 listed)

Pustular, erythrodermic, and/or guttate forms of psoriasis
History of drug-induced psoriasis
Clinically significant flare of psoriasis during the 12 weeks prior to randomization
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 randomization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
80 mg Ixekizumab Dosing Regimens 1, 2, and 3Also: LY2439821Administered SC	Drug	80 mg Ixekizumab Dosing Regimen 2 (Q4W), 80 mg Ixekizumab Dosing Regimen 3 (Q12W), 80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
Time frame: Week 12
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)
Time frame: Week 12
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). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

15 secondary outcomes

Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)
Time frame: Week 12
Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)
Time frame: Week 12
Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period
Time frame: Week 60
Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline
Time frame: Baseline, Week 12
Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score
Time frame: Baseline, Week 12
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline, Week 12
Percent of Body Surface Area (BSA) Involvement of Ps
Time frame: Week 12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Time frame: Baseline, Week 12
Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO)
Time frame: Baseline, Week 12
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)
Time frame: Baseline, Week 12
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)
Time frame: Baseline, Week 12
Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)
Time frame: Baseline, Week 12
Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement
Time frame: Week 12
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
Time frame: Weeks 12: Day 84 and Week 24: Day 168
Percentage of Participants With Anti-ixekizumab Antibodies
Time frame: Baseline through Week 12

Results and safety

Results posted to the registry on 27 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo- Induction Period	431	407
Ixe Q4W - Induction Period	432	408
Ixe Q2W - Induction Period	433	415
Ixe/Placebo- Maintenance Period Primary Pop	0	0
Ixe/Ixe Q12W - Maintenance Period Primary Pop	0	0
Ixe/Ixe Q4W - Maintenance Period Primary Pop	0	0
Placebo Resp/Placebo - Maintenance Period Secondary Pop	0	0
Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop	0	0
Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop	0	0
Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop	0	0
Ixe Q4W - Maintenance Period Relapsed Population	0	0
Placebo Long-Term Extension (LTE)	0	0
Ixe Long-Term Extension	0	0
Total Ixe Long-Term Extension	0	0
Placebo Post-Treatment Follow-Up	0	0
Ixe Q12W Post-Treatment Follow-Up	0	0
Ixe Q4W Post-Treatment Follow-Up	0	0
Ixe Q2W Post-Treatment Follow-Up	0	0

Primary outcome: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)

Time frame: Week 12. Number. Unit: percentage of participants

Measure	Placebo n = 431	Ixe Q4W n = 432	Ixe Q2W n = 433
Value	3.2	76.4	81.8

Placebo vs Ixe Q4W: p <0.001, Regression, Logistic
Placebo vs Ixe Q2W: p <0.001, Regression, Logistic

Population analysed: Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.

Primary outcome: Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)

Time frame: Week 12. Number. Unit: percentage of participants

Measure	Placebo n = 431	Ixe Q4W n = 432	Ixe Q2W n = 433
Value	3.9	82.6	89.1

Placebo vs Ixe Q4W: p <0.001, Regression, Logistic
Placebo vs Ixe Q2W: p <0.001, Regression, Logistic

Population analysed: ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 276 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Induction Period	5 of 431 (1.2%)	128 of 431 (29.7%)	Not reported
Ixe Q4W - Induction Period	12 of 432 (2.8%)	159 of 432 (36.8%)	Not reported
Ixe Q2W - Induction Period	7 of 433 (1.6%)	170 of 433 (39.3%)	Not reported
Ixe/Placebo- Maintenance Period Primary Pop	7 of 226 (3.1%)	83 of 226 (36.7%)	Not reported
Ixe/Ixe Q12W - Maintenance Period Primary Pop	11 of 227 (4.8%)	122 of 227 (53.7%)	Not reported
Ixe/Ixe Q4W - Maintenance Period Primary Pop	14 of 229 (6.1%)	115 of 229 (50.2%)	Not reported
Placebo Resp/Placebo - Maintenance Period Secondary Pop	0 of 16 (0%)	8 of 16 (50%)	Not reported
Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop	24 of 391 (6.1%)	211 of 391 (54%)	Not reported
Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop	8 of 78 (10.3%)	55 of 78 (70.5%)	Not reported
Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop	3 of 62 (4.8%)	34 of 62 (54.8%)	Not reported
Ixe Q4W - Maintenance Period Relapse Pop	11 of 348 (3.2%)	114 of 348 (32.8%)	Not reported
Placebo Long-Term Extension	1 of 26 (3.8%)	8 of 26 (30.8%)	Not reported
Ixe Long-Term Extension	134 of 1,054 (12.7%)	414 of 1,054 (39.3%)	Not reported
Total Ixe Long-Term Extension	134 of 1,075 (12.5%)	414 of 1,075 (38.5%)	Not reported
Placebo Post-Treatment Follow-Up	2 of 18 (11.1%)	3 of 18 (16.7%)	Not reported
Ixe Q12W Post-Treatment Follow-Up	0 of 25 (0%)	2 of 25 (8%)	Not reported
Ixe Q4W Post Treatment Follow-Up

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38647975Egeberg A, Hawkes JE, Somani N, Burge R, See K, Gallo G, McKean-Matthews M, Gooderham M, Han G, Armstrong A. Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60. Dermatol Ther (Heidelb). 2024 Apr;14(4):1007-1018. doi: 10.1007/s13555-024-01147-7. Epub 2024 Apr 22.
Derived from this study: PubMed 37400681Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
Derived from this study: PubMed 35279805Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.
Derived from this study: PubMed 32200512Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.
Derived from this study: PubMed 27299809Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.
Derived from this study: PubMed 26953848Armstrong AW, Lynde CW, McBride SR, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

104 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 80 mg Ixekizumab Dosing Regimens 1, 2, and 3 in people with Psoriasis, run by Eli Lilly and Company at 104 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Germany, Canada, Japan, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01474512, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.