Clinical Trials Register

Summary
EudraCT Number:	2011-002970-22
Sponsor's Protocol Code Number:	I1F-MC-RHAZ
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002970-22

A.3

Full title of the trial

A Multicenter Study with a Randomized, Double-Blind,
Placebo-Controlled Induction Dosing Period Followed by
a Randomized Maintenance Dosing Period and a Long-
Term Extension Period to Evaluate the Efficacy and
Safety of LY2439821 in Patients with Moderate-to-Severe
Plaque Psoriasis

Studio multicentrico con un Periodo di trattamento di induzione randomizzato, in doppio cieco, controllato verso placebo seguito da un Periodo di trattamento di mantenimento randomizzato e da un Periodo di estensione a lungo termine per la valutazione dell'™efficacia e della sicurezza di LY2439821 in pazienti con psoriasi a placche da moderata a grave

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Phase 3 Study in Moderate to Severe Psoriasis Patients

Studio di fase 3 per pazienti affetti da psoriasi da moderata a grave

A.3.2

Name or abbreviated title of the trial where available

UNCOVER-1

A.4.1

Sponsor's protocol code number

I1F-MC-RHAZ

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ELI LILLY AND COMPANY
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Eli Lilly and Company
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Eli Lilly and Company
B.5.2	Functional name of contact point	Clinical trial information
B.5.3	Address:
B.5.3.1	Street Address	----
B.5.3.2	Town/ city	----
B.5.3.3	Post code	----
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	---
B.5.5	Fax number	---
B.5.6	E-mail	EU_Lilly_Clinical_Trials@lilly.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	LY2439821
D.3.2	Product code	LY2439821
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LY2439821
D.3.9.1	CAS number	1143503-69-8
D.3.9.2	Current sponsor code	LY2439821
D.3.9.3	Other descriptive name	Anti-IL- 17Monoclonal Antibody(MAb)
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderate to severe chronic plaque psoriasis

Psoriasi a placche da moderata a grave

E.1.1.1

Medical condition in easily understood language

Psoriasis is a skin condition that causes red, raised scaly patches on the skin

La psoriasi è una condizione della pella che causa rossore, chiazze squamose in rilievo/rialzate sulla pelle

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10050577
E.1.2	Term	Psoriatic plaque
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Efficacy of Anti-IL-17 MAb in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks

Valutare l'efficacia di Anti-IL-17 MAb alla Settimana 12 nel trattamento dei pazienti con psoriasi a placche da moderata a grave, misurata in base ai parametri sPGA (static Physician Global Assessment) e PASI (Psoriasis Area and Severity Index)

E.2.2

Secondary objectives of the trial

•Efficacy of Anti-IL-17 MAb in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI over12 and 60 weeks •Quality of life assessments based on patient reported outcomes over 12 and 60 weeks

Valutare l'efficacia di Anti-IL-17 MAb nel trattamento dei pazienti con psoriasi a placche da moderata a grave, misurata in base ai parametri sPGA e PASI oltre 12 e 60 settimane.-Valutazioni della qualità della vita misurata in base ai risultati segnalati dai pazienti oltre 12 e 60 settimane.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Have active plaque psoriasis covering at least 10% body surface area and a PASI score of 12 •Candidate for phototherapy and/or systemic therapy •Have a sPGA score of at least 3

•Presentano psoriasi a placche attiva su almeno il 10% dell’area di superficie corporea e un punteggio PASI di 12; •Candidati alla fototerapia e/o alla terapia sistemica; •Presentano un punteggio sPGA di almeno 3;

E.4

Principal exclusion criteria

•Have pustular, erythrodermic, and/or guttate forms of psoriasis •Have a history of drug-induced psoriasis •Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline •Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; ustekinumab <8 months; rituximab or efalizumab <12 months; or any other biologic agent <5half-lives prior to baseline •Have received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 [mild, such as desonide] or 7 [least potent, such as hydrocortisone] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia) •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study •Have ever received natalizumab or other agents that target alpha-4- integrin •Have participated in any study with IL-17 antagonist including LY2439821 •Have another serious disorder or illness •Have suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months •Have a history of uncontrolled high blood pressure •Have clinical laboratory test results at entry that are outside the normal reference range •Are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug •Are a woman who is lactating or breast feeding •Are a woman and could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study •Are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months •Are a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate •Are a male, you must agree to reduce the risk of your female partner becoming pregnant during the study

•Presentano forme pustolose, eritrodermiche e/o guttate di psoriasi; •Hanno una storia di psoriasi indotta da farmaci; •Hanno avuto un’esacerbazione clinicamente significativa di psoriasi nelle 12 settimane precedenti il basale; •Utilizzo concomitante o recente di qualsiasi agente biologico entro i seguenti periodi di washout: etanercept <28 giorni; infliximab, adalimumab o alefacept <60 giorni; golimumab <90 giorni; ustekinumab <8 mesi; rituximab o efalizumab <12 mesi; o qualsiasi altro agente biologico <5 emivite prima del basale; •Hanno ricevuto terapie sistemiche per la psoriasi (come fototerapia con psoralene e radiazione UVA [PUVA], ciclosporina, corticosteroidi, metotrexato, retinoidi orali, micofenolato mofetile, tioguanina, idrossiurea, sirolimus, azatioprina) o fototerapia (comprese radiazioni UVB o auto-trattamento con solarium) nelle 4 settimane precedenti; oppure hanno ricevuto un trattamento topico per la psoriasi nelle 2 settimane precedenti la randomizzazione (eccezione: sarà consentito l’uso di steroidi topici di classe 6 [lievi, come desonide] o 7 [i meno potenti, come idrocortisone] limitatamente al viso, alle ascelle e/o ai genitali) •Non possono evitare un’esposizione solare eccessiva o l’uso di docce abbronzanti per almeno 4 settimane prima del basale e durante lo studio •Hanno ricevuto natalizumab o altri agenti che hanno come bersaglio l’alfa-4-integrina •Hanno partecipato a qualsiasi studio con antagonista dell’IL-17 comprendente LY2439821 •Soffrono di un altro grave disturbo o malattia •Hanno sviluppato una grave infezione batterica (per esempio, polmonite e cellulite) negli ultimi 3 mesi •Hanno una storia di ipertensione arteriosa non controllata •All’arruolamento presentano esiti degli esami clinici di laboratorio al di fuori dei normali valori di riferimento •Stanno partecipando a un altro studio clinico riguardante un farmaco sperimentale o ne sono stati ritirati negli ultimi 30 giorni •Soggetti di sesso femminile in fase di allattamento •I soggetti di sesso femminile che potrebbero sviluppare una gravidanza durante lo studio dovranno consultare il medico dello studio riguardo ai metodi contraccettivi da adottare per evitare una gravidanza durante lo studio •I soggetti di sesso femminile in post-menopausa devono avere almeno 45 anni e non avere più cicli mestruali da 12 mesi •I soggetti di sesso femminile di età compresa tra 40 e 45 anni che risultano negativi al test di gravidanza e non hanno più cicli mestruali da soli 12 mesi dovranno sottoporsi a ulteriori esami del sangue per verificare se possano partecipare •I soggetti di sesso maschile dovranno acconsentire a ridurre il rischio che le rispettive partner sviluppino una gravidanza durante lo studio

E.5 End points

E.5.1

Primary end point(s)

Static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI)

scala sPGA (static Physician Global Assessment)e punteggio PASI (Psoriasis Area and Severity Index)

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

Secondary end point(s)

•PASI and sPGA •Quality of life assessments

PASI e sPGA)- Valutazioni della qualità della vita

E.5.2.1

Timepoint(s) of evaluation of this end point

At Week 12 and Week 60

Alla settimana 12 e settimana 60

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Canada

Japan

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

End of study is the date of the last visit or last scheduled procedure for the last active subject in the study.

Il termine dello studio è la data dell'ultima visita o dell'ultima procedura programmata per l'ultimo paziente attivo nello studio.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1000

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

296

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

432

F.4.2.2

In the whole clinical trial

1296

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subject will return to their normal standard of care therapy as determined by their physician.

I pazienti ritorneranno alla normale terapia standard così come stabilito dal proprio medico.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-03-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-09-20

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