Clinical Trials Register

Summary
EudraCT Number:	2016-005025-37
Sponsor's Protocol Code Number:	RD.03.SPR.114322
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-09-22
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2016-005025-37

A.3

Full title of the trial

A randomized, double-blind, multi-center, parallel-group, placebo-controlled dose-ranging study to assess the efficacy and safety of nemolizumab (CD14152) in moderate-to-severe atopic dermatitis subjects with severe pruritus receiving topical corticosteroids

Wieloośrodkowe badanie kliniczne prowadzone w grupach równoległych metodą podwójnie ślepej próby z zastosowaniem randomizacji i placebo, mające na celu ocenę skuteczności i bezpieczeństwa nemolizumabu (CD14152) podawanego w różnych dawkach chorym stosującym miejscowe kortkosteroidy na atopowe zapalenie skóry o nasileniu umiarkowanym do ciężkiego, z towarzyszącym uporczywym świądem.

A.3.1

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

Dose-ranging study of nemolizumab in atopic dermatitis

A.3.2

Name or abbreviated title of the trial where available

Dose-ranging study of nemolizumab in atopic dermatitis

A.4.1

Sponsor's protocol code number

RD.03.SPR.114322

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03100344

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

P/106/2015

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GALDERMA R&D, SNC
B.1.3.4	Country	France
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	GALDERMA R&D, SNC
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GALDERMA R&D, SNC
B.5.2	Functional name of contact point	RA CTA Coordinator
B.5.3	Address:
B.5.3.1	Street Address	Les Templiers, 2400 route des Colles
B.5.3.2	Town/ city	Biot
B.5.3.3	Post code	06410
B.5.3.4	Country	France
B.5.4	Telephone number	+33(0)4 93 95 70 85
B.5.5	Fax number	+33(0)4 92 95 21 31
B.5.6	E-mail	cta.coordinator@galderma.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	CD14152 100mg powder (Nemolizumab)
D.3.2	Product code	CD14152/CIM331
D.3.4	Pharmaceutical form	Powder and solution for 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	Nemolizumab
D.3.9.2	Current sponsor code	CD14152/CIM331
D.3.9.3	Other descriptive name	Humanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A
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	100
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	Powder and solution for 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

Atopic dermatitis

E.1.1.1

Medical condition in easily understood language

Eczema

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10014184
E.1.2	Term	Eczema
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

The primary objective is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe AD subjects with severe pruritus receiving , Topical Cortico Steroid who were not adequately controlled with topical treatments.

E.2.2

Secondary objectives of the trial

The secondary objectives are to evaluate the safety of nemolizumab and to characterize its pharmacokinetic (PK) profile.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female subjects ≥ 18 years (or legal age when higher)

- Chronic AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]), that has been present for at least 2 years before the visit

- Eczema Area and Severity Index (EASI) score ≥ 12

- IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe)

- AD involvement ≥ 10% of BSA

- Severe pruritus, defined as average of pruritus Numeric Rating Score (NRS) for the maximum intensity ≥ 7 during the 7 days prior to the visit.
NOTE: A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.

- Documented recent history (within 6 months before the visit) of inadequate response to topical medications

E.4

Principal exclusion criteria

- Body weight < 45 kg

- Subjects with a medical history of asthma that fulfil any one or more of the scenarios below:
* Had an asthma exacerbation requiring hospitalization in the last 12 months before screening visit
* Whose asthma has not been well-controlled (i.e. symptoms >2 days per week, nighttime awakenings >1-3 times per week, or some interference with normal activities) during the last 3 months before the screening visit
* Peak Expiratory Flow (PEF) <80% of the predicted value

- Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period.

- Pregnant women (with a positive serum pregnancy test result at the screening visit), breastfeeding women, or women planning to become
pregnant during the clinical trial

- History of intolerance to low or mid potency TCS or for whom TCS is not advisable (e.g. hypersensitivity to TCS or to any other ingredient
contained in the TCSs to be used in the study, significant skin atrophy)

E.5 End points

E.5.1

Primary end point(s)

Percentage change in EASI

E.5.1.1

Timepoint(s) of evaluation of this end point

from baseline to week 24

E.5.2

Secondary end point(s)

1. Proportion of subjects achieving IGA success
2. Percent change in EASI
3. Absolute and percent change of the peak and average pruritus
4. Proportion of subjects with an improvement of weekly pruritus peak
5. Absolute and percent change in weekly sleep disturbance
6. Proportion of subjects achieving pruritus categorical scale success
7. Proportion of subjects achieving 50%, 75% or 90% reduction from baseline in EASI score
8. Absolute and percent change in scoring atopic dermatitis

E.5.2.1

Timepoint(s) of evaluation of this end point

1. at each visit up to week 24
2. from baseline at each visit up to week 24
3. from baseline in weekly at each visit up to week 24
4. from baseline to week 24
5. from baseline to week 24
6. at week 24
7. from baseline to week 24
8. from baseline to week 24

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

France

Germany

Poland

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

LVLS

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.1.1.1

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:

166

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

138

F.4.2.2

In the whole clinical trial

351

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)

None

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

2017-12-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-09-21

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