A Study of Ixekizumab Versus Adalimumab in Participants With Psoriatic Arthritis

A 52-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab versus Adalimumab in Patients with Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive - SPIRIT-H2H

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004585-25-HU

Enrollment

550

Registered

2017-04-10

Start date

2017-05-26

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000018188

Interventions

Trade Name: Taltz Pharmaceutical Form: Solution for injection in pre-filled syringe Trade Name: Humira Product Name: Humira Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints Presence of active plaque psoriasis Men must agree to use a reliable method of birth control or remain abstinent during the study Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment 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 495 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: Current or prior use of biologic agents for treatment of Ps or PsA Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab Serious disorder or illness other than psoriatic arthritis Serious infection within the last 3 months Women who are breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI 100) ; Secondary Objective: To assess whether ixekizumab is noninferior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by ACR50 To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by PASI 100 To assess the effect of treatment with ixekizumab compared with adalimumab over 52 weeks as measured by various efficacy and quality of life outcomes ; Primary end point(s): Proportion of Participants Simultaneously Achieving American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 ;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Main Objective: To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI 100) ; Secondary Objective: To assess whether ixekizumab is noninferior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by ACR50 To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by PASI 100 To assess the effect of treatment with ixekizumab compared with adalimumab over 52 weeks as measured by various efficacy and quality of life outcomes ; Primary end point(s): Proportion of Participants Simultaneously Achieving American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 ;Timepoint(s) of evaluation of this end point: Week 24

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of Participants Achieving ACR50 Proportion of Participants Achieving PASI100 Change from Baseline in Tender Joint Count (TJC) Change from Baseline in Swollen Joint Count (SJC) Change from Baseline in Participant's Assessment of Pain VAS Change from Baseline in Participant's Global Assessment of Disease Activity Change from Baseline in Physician's Global Assessment of Disease Activity Change from Baseline in C-Reactive Protein (CRP) Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Proportion of Participants Simultaneously Achieving ACR50 and PASI100 Change from Baseline in Disease Activity Score-CRP (DAS28-CRP) Proportion of Participants Achieving Minimal Disease Activity (MDA) Proportion of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Change from Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified) Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline Change from Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants with Dactylitis at Baseline Change from Baseline in Psoriasis Body Surface Area (BSA) Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with Fingernail Involvement at Baseline Change from Baseline in the Itch NRS Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score	—

Measure

Time frame

Secondary end point(s): Proportion of Participants Achieving ACR50 Proportion of Participants Achieving PASI100 Change from Baseline in Tender Joint Count (TJC) Change from Baseline in Swollen Joint Count (SJC) Change from Baseline in Participant's Assessment of Pain VAS Change from Baseline in Participant's Global Assessment of Disease Activity Change from Baseline in Physician's Global Assessment of Disease Activity Change from Baseline in C-Reactive Protein (CRP) Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Proportion of Participants Simultaneously Achieving ACR50 and PASI100 Change from Baseline in Disease Activity Score-CRP (DAS28-CRP) Proportion of Participants Achieving Minimal Disease Activity (MDA) Proportion of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) Change from Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified) Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline Change from Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants with Dactylitis at Baseline Change from Baseline in Psoriasis Body Surface Area (BSA) Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with Fingernail Involvement at Baseline Change from Baseline in the Itch NRS Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score

—

Countries

Argentina, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026