Clinical trial NCT05855967: A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
Official title: A 24-Week Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety of Ixekizumab in Patients With Moderate-to-Severe Plaque Psoriasis or Active Psoriatic Arthritis in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Psoriatic Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to investigate the safety and tolerability of ixekizumab in participants in India with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA)


Eligibility criteria: Inclusion Criteria:

All participants:

* Male or nonpregnant, nonbreastfeeding female participants.

For PsO Participants:

* Present with chronic PsO based on a confirmed diagnosis of chronic PsO vulgaris for at least 6 months prior to baseline
* Have ≥10% Body Surface Area (BSA) of psoriasis at screening (Visit 1) and baseline
* Have both an sPGA score of ≥3 and PASI score ≥12 at screening and baseline

For PsA Participants

* Have a diagnosis of active PsA for at least 6 months (based on a detailed medical history provided by the patient, and a physical exam by the Study Investigator, and/or other evidence such as that provided by joint x-rays, that establishes a history consistent with a diagnosis of active PsA of at least 6 months' duration) and currently meet the Classification for PsA (CASPAR) criteria.
* Have active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints, as determined by the Tender and Swollen Joint Count Assessment Form at screening and baseline.
* Presence of active PsO or a documented history of psoriasis.

Exclusion Criteria:

* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.
* Have a history of drug-induced PsO.
* Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study.
* Had any major surgery within 8 weeks prior to baseline (Week 0; Visit 2), or will require such during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
* Have diagnosis or history of malignant disease within the 5 years prior to baseline
* Have any other active or recent infection within 4 weeks of baseline

For PsO Participants:

* Have received systemic non-biologic PsO therapy (within 4 weeks prior to baseline)
* Have pustular, erythrodermic, and/or guttate forms of PsO
* Had a clinically significant flare of PsO during the 12 weeks prior to baseline (Week 0).
* Have allergy to rubber or latex.

For PsA Participants:

* Have used conventional synthetic disease-modifying antirheumatic drug (csDMARDs) other than methotrexate (MTX), leflunomide, sulfasalazine, or cyclosporine in the 8 weeks prior to baseline
* Have received treatment with interleukin (IL)17 or IL-12/23 targeted Mab therapy
* Are currently receiving treatment with any biologic or small molecule therapy for PsA or PsO, including investigational therapies (such as, but not limited to, a tumor necrosis factor inhibitor (TNFi), IL-1 receptor antagonists, IL-6 inhibitor, anti-IL12/23p40, T cell or B cell targeted therapies, phosphodiesterase (PDE) 4 inhibitors, or Janus Kinase (JAK) inhibitors), or have received denosumab.
* Have had surgical treatment of a joint within 8 weeks prior to baseline or will require such up to Week 24.

Primary outcomes:
measure: Percentage of Participants with Plaque Psoriasis and with Psoriatic Arthritis Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieve 75% Improvement from Baseline in the Psoriasis Area and Severity Index 75 (PASI 75)
timeFrame: Week 12
measure: Percentage of Participants with a Static Physician Global Assessment (sPGA) Score of 0 or 1 (0,1)
timeFrame: Week 12
measure: Percentage of PsA Participants Who Achieve 20% Improvement from Baseline in American College of Rheumatology 20 (ACR20)
timeFrame: Week 24
Other outcomes:
Locations:
city: Vizag
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Raipur
country: India
facility: All India Institute of Medical Sciences
state: Chhattisgarh
city: Ahmedabad
country: India
facility: V.S. General Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Amber Clinic
state: Gujarat
city: Ahmedabad
country: India
facility: B. J. Medical College & Civil Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: GMERS Medical College & Hospital
state: Gujarat
city: Surat
country: India
facility: Tristar Hospital
state: Gujarat
city: Mangalore
country: India
facility: Father Muller Medical College Hospital
state: Karnataka
city: Navi Mumbai
country: India
facility: Dr. D. Y. Patil Medical College & Hospital
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Oyster & Pearl Hospitals (Phadnis Clinic Pvt. Ltd.)
state: Maharashtra
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
state: Punjab
city: Kolkata
country: India
facility: Wizderm Specialty Skin And Hair Clinic
state: West Bengal
city: Kolkata
country: India
facility: Medical College & Hospital
state: West Bengal
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: