A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Conditions

• Psoriatic Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Administered SC
• Ixekizumab 80 mg Q4W — DRUG
  Administered SC
• Ixekizumab 80 mg Q2W — DRUG
  Administered SC

Study Details

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

Key Dates

Start date

Dec 31, 2014

Status verified

Sep 2019

Primary completion

Sep 9, 2016

Completion

Jun 26, 2019

Study Design

Enrollment

363 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)
  Blinded Treatment Period (Week(wk) 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22, and 24.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Wks 16,18,20,22,24. Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q2W at week 0 and continued on ixe 80 mg Q2W during the Extension Period. Pts who received ixekizumab 80 mg Q2W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
• Experimental: Ixekizumab 80 mg Q4W
  Blinded Treatment Period (Week 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q4W given on Wks 4, 8 and 12 alternating with placebo for ixe injections Q4W given on Wks 2,6,10,14,18, and 22.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Wks 16 and 20 alternating with placebo for ixe injections Q4W given on Wks 18 and 22.Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q4W at week 0 and continued on ixe 80 mg Q4W during the Extension Period.Pts who received ixekizumab 80 mg Q4W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
• Placebo Comparator: Placebo
  Blinded Treatment Period (Wk 0-24): Pts received placebo for Ixe as 2 SC injections followed by 1 SC injection Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22 and 24. Pts initially randomized to placebo treatment group in the double blind treatment period,flagged as IR at Wk 16,re-randomized to ixe 80 mg Q2W/Q4W for the remainder of the current period and following period. Extended Treatment Period (Wk 24-156): Pts who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W/Q4W during the Extension Period.Pts who remained on placebo at the completion of the double blind treatment period received the first dose of ixe (160 mg starting dose) at Wk 24.Pts who were IRs at Wk 16 and were re-randomized to ixe at Wk 16 received the first dose of ixe (160 mg starting dose) at Wk 16. Pts who received placebo,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20) [ Time Frame: Week 24 ]

Locations (59)

Find similar trials in Birmingham, AL

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