Ixekizumab
DrugAdministered SC
Other names: LY2439821
NCT Number: NCT05855967
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)
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Notify Me18 year and older
All sexes
Interventional
Phase 4
King George Hospital, Vizag, Andhra Pradesh, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants:
For PsO Participants:
For PsA Participants
Exclusion criteria
For PsO Participants:
For PsA Participants:
Administered SC
Other names: LY2439821
Time frame: Week 0 to Week 24
Time frame: 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.
Time frame: 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.
Time frame: Week 24
The ACR 20 is defined as:
Eli Lilly and Company
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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