Clinical trial · Interventional
A Study in Participants With Moderate to Severe Psoriasis
A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
NCT01107457CI-TRIAL-00040804completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixekizumab | Biological | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- 10 mg Ixekizumab
- description
- 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.
- interventionNames
- Biological: Ixekizumab
- type
- EXPERIMENTAL
- label
- 25 mg Ixekizumab
- description
- 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.
- interventionNames
- Biological: Ixekizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDLangley 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 25693783
- DERIVEDGordon 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 25242558
- DERIVEDLeonardi 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 22455413