A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India

Phase 4

Completed

Conditions: Psoriatic Arthritis
Plaque Psoriasis

Interventions: Drug: Ixekizumab

Registration Number: NCT05855967

Lead Sponsor: Eli Lilly and Company

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 250

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 static Physician's Global Assessment (sPGA) score of ≥3 and Psoriasis Area and Severity Index (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Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists.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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ixekizumab - PsO With no Active PsA	Ixekizumab	Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received: * Ixekizumab 160 milligram (mg) subcutaneous (SC) injection as loading dose at Week 0, followed by; * Ixekizumab 80 mg SC injection every 2 weeks (Q2W) at Week 2, 4, 6, 8, and 10 * Ixekizumab 80 mg SC injection every 4 weeks (Q4W) at Week 12, 16, and 20
Ixekizumab - Active PsA	Ixekizumab	Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received: * Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by; * Ixekizumab 80 mg SC injection Q2W at Week 2, 4, 6, 8, and 10 * Ixekizumab 80 mg SC injection Q4W at Week 12, 16, and 20 Participants with active PsA without moderate to severe PsO received: * Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by * Ixekizumab 80 mg SC injection Q4W at Week 4, 8, 12, 16, and 20.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24	Week 0 to Week 24	* An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect. * TEAE is defined as an event that first occurred or worsened in severity after baseline and on or prior to the date of the last visit within the treatment period.

Secondary Outcome Measures

Name	Time	Method
PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12	Week 12	Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.
PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal)	Week 12	The sPGA is an assessment by the physician to determine participant's overall psoriatic lesions, at a given time point. For the analysis of responses, the participant's psoriasis indication is assessed on a 5-point scale as: 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe) incorporating an assessment of the severity of the three primary signs of the disease: induration, erythema, and degree of scaling. The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for induration, erythema and degree of scaling. Scores for induration, erythema and scaling are then summed, and the mean of these 3 scores produces the overall sPGA score. Participants with an sPGA score of 0 (clear) or 1 (minimal) were considered responders and are reported here.
Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24	Week 24	The ACR 20 is defined as: * 20% improvement from baseline in both tender joint count (68 counts) and swollen joint count (66 counts) * 20% improvements improvement in at least three of the following five items: Patient's global assessment of arthritis pain (measured on a 100-mm visual analog scale \[VAS\]); Patient's global assessment of disease activity (measured on a 100-mm VAS); Physician's global assessment of disease activity (measured on a 100-mm VAS); Patient's assessment of physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI); Acute-phase reactant as measured by high-sensitivity C-reactive protein (hs-CRP) assay.

Trial Locations

Locations (14): King George Hospital
🇮🇳
Vizag, Andhra Pradesh, India
All India Institute of Medical Sciences
🇮🇳
Raipur, Chhattisgarh, India
V.S. General Hospital
🇮🇳
Ahmedabad, Gujarat, India
Amber Clinic
🇮🇳
Ahmedabad, Gujarat, India
B. J. Medical College & Civil Hospital
🇮🇳
Ahmedabad, Gujarat, India
GMERS Medical College & Hospital
🇮🇳
Ahmedabad, Gujarat, India
Tristar Hospital
🇮🇳
Surat, Gujarat, India
Father Muller Medical College Hospital
🇮🇳
Mangalore, Karnataka, India
Dr. D. Y. Patil Medical College & Hospital
🇮🇳
Navi Mumbai, Maharashtra, India
Grant Medical Foundation - Ruby Hall Clinic
🇮🇳
Pune, Maharashtra, India
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King George Hospital
🇮🇳Vizag, Andhra Pradesh, India