A Study of the Early Activity of Ixekizumab (LY2439821) in Moderate-to-Severe Psoriasis

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02387801

I1F-US-RHBO (Other Identifier)

15454

Details and patient eligibility

About

To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline
• Active psoriatic skin lesions of plaque psoriasis (Ps)
• Are a candidate for phototherapy and/or systemic therapy
• Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
• Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion criteria

• Are unable to commit to the photography schedule for the duration of the study
• Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab
• Serious disorder or illness other than psoriasis
• Serious infection within the last 3 months
• Breastfeeding or nursing (lactating) women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Ixekizumab Dosing Q2W

Experimental group

Description:

160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.

Treatment:

Drug: Ixekizumab

Ixekizumab Dosing Q4W

Experimental group

Description:

160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.

Treatment:

Drug: Ixekizumab