Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Plaque Psoriasis Clinical Trial

— Ixora-peds  

Official title:

Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073200
• Other study ID #: 16367
• Secondary ID: I1F-MC-RHCD2016-
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2017
• Est. completion date: March 23, 2021

Study information

• Verified date: August 16, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: March 23, 2021
• Est. primary completion date: February 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.

• Have Psoriasis Area and Severity Index (PASI) score =12 and a Static Physician Global Assessment (sPGA) =3 and body surface area involvement =10% at screening and baseline.

• Are candidates for phototherapy or systemic treatment or considered by the investigator as not adequately controlled by topical therapies.

• Male subjects agree to use a reliable method of birth control during the study.

• Female subjects: Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.

• Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.

• All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the American Academy of Paediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.

Exclusion Criteria:

• Have pustular, erythrodermic, and/or guttate forms of psoriasis.

• Have drug-induced psoriasis.

• Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).

• Participants with a documented history of immune deficiency syndrome.

• Have any other active or recent infection, including chronic or localized infections, within 4 weeks of baseline.

• Subjects with a known history of malignancy, lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy.

• Have used any therapeutic agent targeted at reducing interleukin-17.

• Have received other therapies within the specified time frames prior to screening (see below):

• adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other biologic disease-modifying antirheumatic drug 5 half-lives.

• systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above, eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy [psoralen plus ultraviolet A]) in the previous 4 weeks.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Ixekizumab
Administered SC
• Placebo
Administered SC
• Etanercept
Administered SC

Locations

Country	Name	City	State
Argentina	Instituto de Neumonología y Dermatología	Buenos Aires
Argentina	Psoriahue Medicina Interdisciplinaria	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Fundación Estudios Clínicos- Servicio de Dermatología	Rosario	Santa Fe
Canada	Institute for Skin Advancement	Calgary	Alberta
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Hospital Ste Justine	Montreal	Quebec
Canada	K. Papp Clinical Research Inc	Waterloo	Ontario
Czechia	Detska fakultni nemocnice	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni Nemocnice Plzen	Plzen-Bory
Czechia	LF UK - Fakultni poliklinika	Praha
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Nemocnice Na Bulovce	Praha 8
France	Centre hospitalier universitaire Pellegrin	Bordeaux
France	Hôpital Femme Mère Enfant	Bron
France	CHU de Nice Hopital de L'Archet	Nice
Germany	ISA GmbH	Berlin
Germany	Universitätsklinikum Erlangen	Erlangen	Bayern
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz	Rheinland-Pfalz
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika	Debrecen	Hajdu-Bihar
Hungary	Oroshaza Varosi Onkormanyzat Korhaza	Oroshaza
Hungary	SZTE AOK Borgyogyaszati es Allergologiai Klinika	Szeged	Csongrad
Hungary	Allergo-Derm Bakos Kft	Szolnok	Jasz-Nagykun-Szolnok
Mexico	Hospital Infantil de Mexico	Ciudad de Mexico	Federal District
Mexico	RM Pharma Specialists S.A. de C.V.	Distrito Federal
Mexico	Hospital Univ. Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	Arke Estudios Clinicos S.A. de C.V.	Veracruz
Netherlands	Universitair Medisch Centrum St Radboud Nijmegen	Nijmegen
Poland	"Dermed" Centrum Medyczne Sp. z o.o.	Lodz
Poland	Centralny Szpital Kliniczny MSW	Warszawa
Poland	DermMEDICA Sp. z o.o.	Wroclaw
Puerto Rico	Office of Dr. Samuel Sanchez PSC	Caguas
Puerto Rico	Grupo Dermatologico de Carolina	Carolina
Puerto Rico	Ponce School of Medicine CAIMED Center	Ponce
Puerto Rico	GCM Medical Group PSC	San Juan
Russian Federation	GBUZ Clinical dermatology and venereological dispensary	Krasnodar
Russian Federation	Center of Children's Health	Moscow
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina Dermatology and skin Cancer Cen	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Olympian Clinical Research	Clearwater	Florida
United States	University of Missouri	Columbia	Missouri
United States	Modern Research Associates PLLC	Dallas	Texas
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Dermatology and Skin Surgery Center	Exton	Pennsylvania
United States	Wright State Physicians Dermatology	Fairborn	Ohio
United States	Tien Q. Nguyen, MD inc. DBA First OC Dermatology	Fountain Valley	California
United States	Ohio State Univ College Of Medicine	Gahanna	Ohio
United States	Solutions Through Advanced Research, Inc.	Jacksonville	Florida
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	SSM Health Cardinal Glennon Children's Hospital	Saint Louis	Missouri
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Advanced Medical Research	Sandy Springs	Georgia
United States	The South Bend Clinic	South Bend	Indiana
United States	Forward Clinical Trials, Inc	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Czechia,  France,  Germany,  Hungary,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a =75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)	PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.; Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).	Week 12
Primary	Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)	Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.	Week 12
Secondary	Percentage of Participants With a =90% Improvement in Psoriasis Area and Severity Index (PASI 90)	PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).	Week 12
Secondary	Percentage of Participants With a sPGA (0)	Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.; An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis.	Week 12
Secondary	Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)	PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.; Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).	Week 12
Secondary	Percentage of Participants With a =75% Improvement in Psoriasis Area and Severity Index (PASI 75)	PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).	Week 4
Secondary	Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)	Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.	Week 4
Secondary	Percentage of Participants With an Improvement of =4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of =4	Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing "no itching" and 10 representing "worst itch imaginable.	Week 12
Secondary	Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)	DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms & feelings, daily activities, leisure, work & school , personal relationships, & treatment. The recall period of this scale is over the "last week." Response categories and corresponding scores are: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment).	Week 12
Secondary	Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)	NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis & nail matrix psoriasis by area of involvement in the nail unit. Both fingernail & toenail involvement were assessed.The nail is divided with imaginary horizontal & longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) & nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed & nail matrix psoriasis in each quadrant: 0 = None; = present in one quadrant of nail; = present in two quadrants of nail; = present in three quadrants of nail; = present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed & nail matrix from each quadrant (maximum of 8). Each nail is evaluated, & the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)	Baseline, Week 12
Secondary	Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)	The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent; = Slight; = Moderate; = Severe; = Severest Possible; Percent of Scalp Involved: = <10%; = 10% - 29%; = 30% - 49%; = 50% - 69%; = 70% - 89%; = 90% - 100%; The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease).; LSMean was calculated using treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors.	Baseline, Week 12
Secondary	Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)	PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms & soles on each hand & foot was assessed for erythema, induration, desquamation & percentage of area affected as follows: Erythema (E), Induration (I), & Desquamation (D):0 = None, 1 = Slight, 2 = Moderate, 3 = Severe, 4 = Very Severe; Percent of Palm and Sole Area Covered: 0 = None, 1 = <10%, 2 = 10% - 29%, 3 = 30% - 49%, 4 = 50% - 69%, 5 = 70% - 89%, 6 = 90% - 100% PPASI score is a composite score derived from the sum scores for E, I, & D multiplied by a score for the extent of palm & sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease).	Baseline, Week 12
Secondary	Number of Participants With Anti-Ixekizumab Antibodies	A treatment emergent - antidrug antibody (TE-ADA) positive participant were defined as: a participant with a >= 4-fold increase over a positive baseline antibody titer; or; for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10.	Baseline through Week 48
Secondary	Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)	Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss).	Week 12
Secondary	Percentage of Participants With a =75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)	PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.; Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).	Week 12
Secondary	Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)	Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.	Week 12

External Links

•   Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis