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NCT05855967

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

Completed Phase 4 Results posted Last updated 22 August 2025
What this trial tests

Phase 4 trial testing Ixekizumab in Plaque Psoriasis in 250 participants. Completed in 23 September 2024.

Timeline
27 June 2023
Primary endpoint
8 August 2024
23 September 2024

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment250
Start date27 June 2023
Primary completion8 August 2024
Estimated completion23 September 2024
Sites14 locations across India

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Plaque Psoriasis or Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

SAEs
GroupValue95% CI
Q2W/Q4W Ixekizumab Dosing Regimen1
Q4W Ixekizumab Dosing Regimen0
TEAEs
GroupValue95% CI
Q2W/Q4W Ixekizumab Dosing Regimen60
Q4W Ixekizumab Dosing Regimen8
AESIs
GroupValue95% CI
Q2W/Q4W Ixekizumab Dosing Regimen39
Q4W Ixekizumab Dosing Regimen6
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 Secondary · 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 scal

GroupValue95% CI
Ixekizumab - PsO With no Active PsA86.0
PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal) Secondary · 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

GroupValue95% CI
Ixekizumab - PsO With no Active PsA65.3
Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24 Secondary · 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 re

GroupValue95% CI
Ixekizumab - Active PsA84.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 0 up to 36 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Q2W/Q4W Ixekizumab Dosing Regimen
Serious: 1/209 (0%)
Deaths: 0/209
Q4W Ixekizumab Dosing Regimen
Serious: 0/41 (0%)
Deaths: 0/41

Serious adverse events (1 terms)

ReactionSystemQ2W/Q4W Ixekizumab Dosing …Q4W Ixekizumab Dosing Regi…
Gastroenteritis viralInfections and infestations
Other adverse events (42 terms — click to expand)

ReactionSystemQ2W/Q4W Ixekizumab Dosing …Q4W Ixekizumab Dosing Regi…
PyrexiaGeneral disorders
Latent tuberculosisInfections and infestations
Injection site erythemaGeneral disorders
NasopharyngitisInfections and infestations
Tinea crurisInfections and infestations
Blood creatine phosphokinase increasedInvestigations
HypertriglyceridaemiaMetabolism and nutrition disorders
Body tineaInfections and infestations
Upper respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
Alanine aminotransferase increasedInvestigations
Type 2 diabetes mellitusMetabolism and nutrition disorders
HypertensionVascular disorders
EosinophiliaBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
Dental cariesGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
HyperchlorhydriaGastrointestinal disorders
PainGeneral disorders
AppendicitisInfections and infestations
GastroenteritisInfections and infestations
InfluenzaInfections and infestations
Localised infectionInfections and infestations
Oral candidiasisInfections and infestations
Pulmonary tuberculosisInfections and infestations
PyodermaInfections and infestations
Typhoid feverInfections and infestations
Blood triglycerides increasedInvestigations
C-reactive protein increasedInvestigations
Gamma-glutamyltransferase increasedInvestigations
Weight decreasedInvestigations
Weight increasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
AlopeciaSkin and subcutaneous tissue disorders
Dermatitis acneiformSkin and subcutaneous tissue disorders
Dry skinSkin and subcutaneous tissue disorders
ErythemaSkin and subcutaneous tissue disorders
PruritusSkin and subcutaneous tissue disorders
Skin burning sensationSkin and subcutaneous tissue disorders

Most-reported serious reactions: Gastroenteritis viral.

Data from ClinicalTrials.gov NCT05855967 adverse events section.

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ixekizumab

Trials testing the same drug.

Other recruiting trials for Plaque Psoriasis

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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