NCT01107457

Brief Summary

The primary purpose for this study is to help answer the following research questions

  • The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.
  • Whether ixekizumab can help participants with Psoriasis.
  • How much ixekizumab should be given to participants.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_2

Geographic Reach
2 countries

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 25, 2017

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

April 14, 2010

Results QC Date

April 20, 2016

Last Update Submit

September 10, 2019

Conditions

Psoriasis

Keywords

ModerateSeverePlaqueChronic

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

    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 (none) to 4 (very severe). 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 psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

    Week 12

  • Percentage of PASI Improvement From Baseline to 12 Week Endpoint

    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 (none) to 4 (very severe). 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 psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.

    Baseline to Week 12

Secondary Outcomes (30)

  • Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12

    Week 12

  • Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks

    Baseline Up to 20 Weeks

  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16

    Baseline, Week 16

  • Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16

    Baseline, Week 16

  • Change From Baseline in Patient Global Assessment (PatGA) at Week 12

    Baseline, 12 Weeks

  • +25 more secondary outcomes

Study Arms (7)

10 mg Ixekizumab

EXPERIMENTAL

Part A: 10 milligrams (mg) ixekizumab given subcutaneous (SC) on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.

Biological: Ixekizumab

25 mg Ixekizumab

EXPERIMENTAL

Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC (Q4W). Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.

Biological: Ixekizumab

75 mg Ixekizumab

EXPERIMENTAL

Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.

Biological: Ixekizumab

150 mg Ixekizumab

EXPERIMENTAL

Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.

Biological: Ixekizumab

Placebo

PLACEBO COMPARATOR

Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through approximately week 344.

Biological: IxekizumabDrug: Placebo

120 mg Ixekizumab

EXPERIMENTAL

Part B: (optional) 120 mg ixekizumab given SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Part C: (optional) 80 mg ixekizumab given SC every 4 weeks through approximately week 344.

Biological: Ixekizumab

80 mg Ixekizumab

EXPERIMENTAL

Part B: (optional) Subsequent to an amendment on May 2012, administration changed to 80 mg ixekizumab Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC every 4 weeks through approximately week 344.

Biological: Ixekizumab

Interventions

IxekizumabBIOLOGICAL

Administered subcutaneously

Also known as: LY2439821
10 mg Ixekizumab120 mg Ixekizumab150 mg Ixekizumab25 mg Ixekizumab75 mg Ixekizumab80 mg IxekizumabPlacebo
PlaceboDRUG

Administered subcutaneously

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization.
  • Participant is a candidate for systemic therapy
  • Participant has a Static Physician's Global Assessment (sPGA) score of at least 3 at screening and at randomization
  • Participant has completed the treatment period for part A (at least through week 20)
  • Participant has completed the treatment period for part B

You may not qualify if:

  • Participant has pustular, erythrodermic and/or guttate forms of psoriasis
  • Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry
  • Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept \>28 days, infliximab or adalimumab \>56 days, alefacept \>60 days, ustekinumab \>8 months, or any other biologic agent/monoclonal antibody \>5 half-lives prior to baseline
  • Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A \[PUVA\] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 \[mild, such as desonide\] or 7 \[least potent, such as hydrocortisone\] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia)
  • Participant has donated more than 500 mL of blood within the last month
  • Participant has another serious disorder or illness
  • Participant has suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months
  • Participant has a history of uncontrolled high blood pressure
  • Participant has clinical laboratory test results at entry that are outside the normal reference range
  • Participant is currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
  • Participant is a woman who is lactating or breast feeding
  • If a participant is a woman and could become pregnant during this study, she must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study
  • If a participant is post menopausal woman, she must be at least 45 years of age and have not menstruated for the last 12 months
  • If a participant is a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, she must have an additional blood test to see if you can participate
  • If the participant is male, he must agree to reduce the risk of female partner becoming pregnant during the study
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bakersfield, California, 93309, United States

Location

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New Haven, Connecticut, 06511, United States

Location

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Washington D.C., District of Columbia, 20037, United States

Location

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Miami, Florida, 33175, United States

Location

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Miramar, Florida, 33027, United States

Location

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Newnan, Georgia, 30263, United States

Location

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Arlington Heights, Illinois, 60005, United States

Location

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Skokie, Illinois, United States

Location

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West Dundee, Illinois, 60118, United States

Location

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South Bend, Indiana, 46617, United States

Location

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Boston, Massachusetts, 02114, United States

Location

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Ann Arbor, Michigan, 48109, United States

Location

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St Louis, Missouri, 63117, United States

Location

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Omaha, Nebraska, 68144, United States

Location

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Reno, Nevada, 89511, United States

Location

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Jamaica, New York, 11418, United States

Location

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New York, New York, 10029, United States

Location

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Rochester, New York, 14623, United States

Location

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Stony Brook, New York, 11790, United States

Location

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Winston-Salem, North Carolina, 27103, United States

Location

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Cleveland, Ohio, 44106, United States

Location

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Lake Oswego, Oregon, 97035, United States

Location

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Portland, Oregon, 97223, United States

Location

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Philadelphia, Pennsylvania, 19103, United States

Location

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Knoxville, Tennessee, 37922, United States

Location

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Nashville, Tennessee, 37215, United States

Location

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College Station, Texas, 77845, United States

Location

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Dallas, Texas, 75246, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Norfolk, Virginia, 23507, United States

Location

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Richmond, Virginia, 23294, United States

Location

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Aarhus, 8000, Denmark

Location

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Copenhagen, 2400, Denmark

Location

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Hellerup, 2900, Denmark

Location

Related Publications (3)

  • Langley RG, Rich P, Menter A, Krueger G, Goldblum O, Dutronc Y, Zhu B, Wei H, Cameron GS, Heffernan MP. Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1763-70. doi: 10.1111/jdv.12996. Epub 2015 Feb 18.

    PMID: 25693783DERIVED

  • Gordon KB, Leonardi CL, Lebwohl M, Blauvelt A, Cameron GS, Braun D, Erickson J, Heffernan M. A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2014 Dec;71(6):1176-82. doi: 10.1016/j.jaad.2014.07.048. Epub 2014 Sep 19.

    PMID: 25242558DERIVED

  • Leonardi C, Matheson R, Zachariae C, Cameron G, Li L, Edson-Heredia E, Braun D, Banerjee S. Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis. N Engl J Med. 2012 Mar 29;366(13):1190-9. doi: 10.1056/NEJMoa1109997.

    PMID: 22455413DERIVED

MeSH Terms

Conditions

PsoriasisLymphoma, FollicularPlaque, AmyloidBronchiolitis Obliterans Syndrome

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host Disease

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 21, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2011

Study Completion

July 1, 2016

Last Updated

September 24, 2019

Results First Posted

July 25, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

US(31)DK(3)