A Study in Participants With Moderate to Severe Psoriasis

NCT ID: NCT01107457

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2016-07-31

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.

Detailed Description

The study is a Phase 2 study with 3 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design, Part B is an optional, open label extension design and Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks). Approximately 125 participants will be randomized to 1 of 4 ixekizumab groups or to placebo (approximately 25 participants per group) in Part A. Participants will be evaluated for treatment efficacy and the primary endpoint will be evaluated at week 12. Between week 20 and week 32, participants with a less than 75% improvement in their Psoriasis Area and Severity Index (PASI) score compared to baseline will be eligible to begin Part B. Participants in Part B will receive subcutaneous (SC) injections of ixekizumab 120 milligrams (mg) every 4 weeks through week 236. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Participants in Part C may receive SC injections of ixekizumab 80 mg every 4 weeks for up to an additional 104 weeks through approximately week 340. Participants who complete Part A, Part B, and Part C will have a total study participation of approximately 344 weeks.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

10 mg Ixekizumab

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.

Group Type: EXPERIMENTAL

Ixekizumab

Intervention Type: BIOLOGICAL

Administered subcutaneously

25 mg Ixekizumab

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.

Group Type: EXPERIMENTAL

Ixekizumab

Intervention Type: BIOLOGICAL

Administered subcutaneously

75 mg Ixekizumab

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.

Group Type: EXPERIMENTAL

Ixekizumab

Intervention Type: BIOLOGICAL

Administered subcutaneously

150 mg Ixekizumab

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.

Group Type: EXPERIMENTAL

Ixekizumab

Intervention Type: BIOLOGICAL

Administered subcutaneously

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Ixekizumab

Intervention Type: BIOLOGICAL

Administered subcutaneously

Placebo

Intervention Type: DRUG

Administered subcutaneously

120 mg Ixekizumab

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.

Group Type: EXPERIMENTAL

Ixekizumab

Intervention Type: BIOLOGICAL

Administered subcutaneously

80 mg Ixekizumab

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.

Group Type: EXPERIMENTAL

Ixekizumab

Intervention Type: BIOLOGICAL

Administered subcutaneously

Interventions

Ixekizumab

Administered subcutaneously

Intervention Type: BIOLOGICAL

Placebo

Administered subcutaneously

Intervention Type: DRUG

Other Intervention Names

LY2439821

Eligibility Criteria

Inclusion Criteria

• 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

Inclusion Criterion Specific to Part B

• Participant has completed the treatment period for part A (at least through week 20)

Inclusion Criterion Specific to Part C

• Participant has completed the treatment period for part B

Exclusion Criteria

• 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

• If a participant experienced a serious adverse event during Part A considered possibly related to ixekizumab
• If a participant experienced an adverse event during Part A that the study doctor believes continued ixekizumab treatment could cause harm to the participant.

• If a participant experienced a Serious Adverse Event during Part B considered possibly related to ixekizumab
• If a participant experienced an adverse event during Part B that the study doctor believes continued ixekizumab treatment could cause harm to the participant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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, United States

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.

New Haven, Connecticut, United States

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.

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

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.

Miami, Florida, United States

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Miramar, Florida, United States

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Newnan, Georgia, United States

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Arlington Heights, Illinois, United States

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Skokie, Illinois, United States

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West Dundee, Illinois, United States

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South Bend, Indiana, United States

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Boston, Massachusetts, United States

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.

Ann Arbor, Michigan, United States

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.

St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Jamaica, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Stony Brook, New York, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Lake Oswego, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Knoxville, Tennessee, United States

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.

Nashville, Tennessee, United States

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College Station, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Aarhus, , Denmark

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.

Copenhagen, , Denmark

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.

Hellerup, , Denmark

Countries

United States; Denmark

References

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.

Reference Type: DERIVED

PMID: 25693783 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25242558 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22455413 (View on PubMed)

Other Identifiers

I1F-MC-RHAJ

Identifier Type: OTHER

Identifier Source: secondary_id

12060

Identifier Type: -

Identifier Source: org_study_id