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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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