Phase 2
Completed N=142
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
| Outcome | Result | p-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.
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.