A Phase 2 Study in Patients With Moderate-to-Severe Psoriasis

• Register: EUCTR
• Last refreshed on: 16 August 2016
• Main ID: EUCTR2010-018948-14-DK
• Date of registration: 31/05/2010
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Phase 2 Study in Patients With Moderate-to-Severe Psoriasis
• Scientific title: A Dose-Ranging And Efficacy Study of LY2439821 (an Anti-IL-17 Antibody) in Patients With Moderate-To-Severe Psoriasis
• Date of first enrolment: 29/06/2010
• Target sample size: 125
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018948-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Part B&C: Open label treatment period If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark, United States

Contacts

• Name: Clinical trial information
• Affiliation: Eli Lilly and Company

• Name: Clinical trial information
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion Criteria Common to Both Part A and B:

[1] Ambulatory male or female patients =18 years of age.
[1a] Male patients:
agree to use a reliable method of birth control during the study.
[1b] Female patients:
Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate (<1% per year) during the study.
OR
Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
OR
Post menopausal female patients defined as women >45 years of age who have had a cessation of menses for at least 12 months OR are women between 40 and 45 years of age who test negative for pregnancy, have had a cessation of menses for at least 12 months, and have a Follicle Stimulating Hormone (FSH) value >40 mIU/mL.
[2] Present with chronic plaque psoriasis based on a diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization; at least 10% BSA involvement; and a PASI score of at least 12 at Visits 1 and 2
[30] Are a candidate for systemic therapy.
[31] Have a sPGA score of at least 3 at Visits 1 and 2.

Inclusion Criterion Specific to Part B:

[32] Patients who have completed the treatment period for Part A. A patient is defined as having completed the treatment period for Part A if he/she has completed at least through Week 20.

Inclusion Criterion Specific to Part C
[35] Patients who have completed the treatment period for Part B.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
3. Have pustular, erythrodermic and/or guttate forms of psoriasis.
4. Have had a clinically-significant flare of psoriasis during the 12 weeks prior to randomization.
5. Have 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 or therapeutic sunbathing) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
6. Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days, infliximab or adalimumab <56 days, alefacept <60 days, ustekinumab <8 months, or any other biologic agent <5 half-lives prior to baseline.
7. Current or expected use of concomitant medications or treatments other than those listed in Section 9.8, unless approved by the sponsor.
8. Are currently enrolled in, or have discontinued within the last 30 days (prior to Visit 1) from a clinical trial involving use of an investigational drug or device, or are currently enrolled in any other type of medical research not compatible with this study.
9. Have previously completed or withdrawn from this study.
10. Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical trial within 12 weeks prior to randomization.
11. Have evidence of active infection, such as fever =38.0oC within 5 days of dosing.
12. Have evidence of or test positive for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
13. Are immunocompromised, have had a recent or current serious systemic or local infection (including infectious mononucleosis-like illness or herpes zoster), or have evidence of active or latent tuberculosis
14. Have thyroid-stimulating hormone (TSH) outside of the laboratory’s reference range.
15. Have a history of uncompensated heart failure, fluid overload, myocardial infarction, or evidence of ischemic heart disease or other serious cardiac disease within 12 weeks before randomization.
16. Have a history of chronic liver disease, peripheral vascular disease or cerebrovascular disease, or epilepsy.
17. Have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, could interfere with study conduct.
18 Have uncontrolled arterial hypertension characterized by a repeated systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg.
19 Have current or a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years.
20 Have a history of atopy or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
21 Have laboratory test values outside the reference range for the population or investigative site that are considered clini

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients With Moderate-To-Severe Psoriasis
MedDRA version: 18.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

Product Name: ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Ixekizumab
CAS Number: 1143503-69-8
Current Sponsor code: LY2439821, ixekizumab
Other descriptive name: Anti-IL- 17 Monoclonal Antibody (Mab)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 48-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ixekizumab
CAS Number: 1143503-69-8
Current Sponsor code: LY2439821, ixekizumab
Other descriptive name: Anti-IL- 17 Monoclonal Antibody (Mab)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 80-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: week 12

Main Objective: The primary objective of this study is to test the hypothesis that at least 1 LY2439821 treatment group is superior to placebo in the proportion of adult patients with moderate-to-severe chronic plaque psoriasis who achieve a 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index (PASI 75) and to estimate the percentage PASI improvement by treatment using regression techniques.

Primary end point(s): primary end point a 75% improvement in PASI score (PASI 75).

Secondary Objective: •To test the hypothesis that:
- at least one LY2439821 treatment group is superior to placebo in the proportion of patients with a sPGA score of cleared (0) or minimal (1) with at least a 2 point improvement from baseline at W12
- LY2439821 is superior to placebo in the sPGA at W 12 and to measure the response by treatment group
•To evaluate the proportion of patients who achieve:
- sPGA score of cleared (0) or minimal (1) at W20
- 75% improvement from baseline in the PASI at W20
•To explore:
- relationships between LY2439821 dose regimens and health outcomes
- immunogenicity as measured by anti-LY2439821 antibody titers
- relationships between clinical response and systemic exposure across the dose regimens
•To evaluate:
- safety and tolerability of LY2439821
- sustained efficacy in patients who experience treatment benefit at W20
- LY2439821 pharmacokinetics after multiple doses
- effect of long term LY2439821 treatment on disease severity as measured by PASI & sPGA

Secondary Outcome(s)

Secondary end point(s): - Static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI).
- Quality of life assessments based on patient reported outcomes over 12 and 20 weeks

Timepoint(s) of evaluation of this end point: through Week 20

Secondary ID(s)

I1F-MC-RHAJ(d)

Source(s) of Monetary Support

Eli Lilly and Company