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Phase 2 Completed N=142 Randomized Quadruple-blind Treatment

A Study in Participants With Moderate to Severe Psoriasis

Source: ClinicalTrials.gov NCT01107457 ↗
Enrolled (actual)
142
Serious AEs
8.2%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement — 7.7; 28.6; 76.7; 82.8 percentage of participants — p=0.079

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
97.3
PRIMARY
Percentage of PASI Improvement From Baseline to 12 Week Endpoint
16.22; 49.33; 78.48; 85.69; 87.12 <0.001 sig
SECONDARY
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
7.7; 25.0; 70.0; 72.4; 71.4
SECONDARY
Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks
17; 21; 21; 17; 13
SECONDARY
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16
-0.86; -1.97; -2.10; -2.17; -2.81; 0.17
SECONDARY
Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16
-0.49; -1.56; -1.48; -2.13; -2.21
SECONDARY
Change From Baseline in Patient Global Assessment (PatGA) at Week 12
-0.6; -1.1; -2.3; -2.9; -2.5
SECONDARY
Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12
3.87; -4.32; -19.36; -21.24; -34.24
SECONDARY
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16
-0.05; -5.35; -8.78; -7.97; -2.38; 0.21
SECONDARY
Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))
1; 0; 0; 1; 3; 0
SECONDARY
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16
-1.91; 0.71; -0.83; -2.64; -1.96; -3.38
SECONDARY
Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16
-1.22; 2.41; 1.95; 3.94; 5.72; -0.56
SECONDARY
Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12
2.21; -4.85; -3.65; -15.89; -19.91
SECONDARY
Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12
-1.0; -6.4; -4.6; -3.4; -12.8
SECONDARY
Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12
-7.3; -10.2; -15.8; -15.0; -17.2
SECONDARY
Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)
0.0177
SECONDARY
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16
-1.24; -6.35; -6.59; -8.39; -8.17
SECONDARY
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12
3.50; 8.20; 13.56; 14.99; 15.38
SECONDARY
Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)
0; 50.0; 59.1; 56.5; 82.6
SECONDARY
Percentage of PASI Improvement From Baseline Through 32 Weeks
80.55; 85.60; 85.16; 88.11
SECONDARY
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
33.3; 45.5; 47.8; 65.2
SECONDARY
Percentage of Participants With Anti-Ixekizumab Antibodies
4.0; 54.2; 40.0; 17.2; 22.2
SECONDARY
Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)
78.4
SECONDARY
Number of Treatment Emergent Adverse Events up to 344 Weeks
105
SECONDARY
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
-3.0; -2.8
SECONDARY
Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)
40; 26; 4; 2; 2; 0
SECONDARY
Change From Baseline in Pain Visual Analog Scale (VAS)
-13.25
SECONDARY
Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis
-33.62
SECONDARY
Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis
-19.89
SECONDARY
Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis
-9.10
SECONDARY
Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
97.3
SECONDARY
Change From Baseline in Dermatology Life Quality Index (DLQI)
-9.2

Eligibility Criteria

Inclusion Criteria Common to Both Part A:

  • 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 Common to Part A, B and C:

  • 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

Exclusion Criteria Specific to B:

  • 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.

Exclusion Criteria Specific to C:

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01107457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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