A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis (IXORA-P)

Lilly

Status and phase

Completed

Phase 3

Conditions

Plaque Psoriasis

Treatments

Drug: Placebo

Drug: Ixekizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02513550

2015-000190-12 (EudraCT Number)

I1F-MC-RHBP (Other Identifier)

15988

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

Full description

The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.

Enrollment

1,257 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Present with chronic plaque psoriasis for at least 6 months prior to enrollment
At least 10% BSA of psoriasis at screening and at enrollment
sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
Candidates for phototherapy and/or systemic therapy
Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion criteria

Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
History of drug-induced psoriasis
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
Concurrent or recent use of any biologic agent
Have participated in any study with ixekizumab
Received a live vaccination within 12 weeks prior to enrollment
Serious disorder or illness other than psoriasis
Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
Major surgery within 8 weeks of baseline, or will require surgery during the study
Breastfeeding or nursing (lactating) women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,257 participants in 6 patient groups

80 mg Ixekizumab Q2W

Experimental group

Description:

160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52. Placebo administered SQ, Q2W to maintain blind.

Treatment:

Drug: Ixekizumab

Drug: Placebo

80 mg Ixekizumab Q4W

Experimental group

Description:

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.

Treatment:

Drug: Ixekizumab

Drug: Placebo

80 mg Ixekizumab Q4W/Q2W

Experimental group

Description:

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.

Treatment:

Drug: Ixekizumab

Drug: Placebo

80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort

Experimental group

Description:

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.

Treatment:

Drug: Ixekizumab

Drug: Placebo

80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort

Experimental group

Description:

160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.

Treatment:

Drug: Ixekizumab

Drug: Placebo

80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort

Experimental group

Description:

Treatment:

Drug: Ixekizumab

Drug: Placebo