Clinical Trials Register

Summary
EudraCT Number:	2018-000331-27
Sponsor's Protocol Code Number:	ANB020-005
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-06-20
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2018-000331-27

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects with Moderate-to-Severe Atopic Dermatitis

Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení paralelních skupin s různým rozsahem dávkování posuzující účinnost, bezpečnost a farmakokinetický profil přípravku ANB020 podávaného dospělým pacientům se středně těžkou až těžkou atopickou dermatitidou.

A.3.1

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

Efficacy, Safety, and Pharmacokinetic Profile of ANB020 in Adults with Moderate to Severe Atopic Dermatitis

A.4.1

Sponsor's protocol code number

ANB020-005

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03533751

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	AnaptysBio, Inc.
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	AnaptysBio, Inc.
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	AnaptysBio, Inc.
B.5.2	Functional name of contact point	AnaptysBio Clinical Trials Info
B.5.3	Address:
B.5.3.1	Street Address	Suite 200, 10421 Pacific Center Court
B.5.3.2	Town/ city	San Diego, California
B.5.3.3	Post code	CA 92121
B.5.3.4	Country	United States
B.5.4	Telephone number	+18583626387
B.5.6	E-mail	clinicaltrialinfo@anaptysbio.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	Etokimab
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	anti-IL-33 monoclonal antibody
D.3.9.2	Current sponsor code	ANB020
D.3.9.3	Other descriptive name	Humanized monoclonal antibody
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)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
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 Atopic Dermatitis

E.1.1.1

Medical condition in easily understood language

Moderate-to-Severe Atopic Dermatitis

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	10012438
E.1.2	Term	Dermatitis atopic
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 of this study is to evaluate the effects of ANB020 on skin lesions.

E.2.2

Secondary objectives of the trial

Secondary Objective:
To evaluate the safety and tolerability of ANB020.
To evaluate the effects of ANB020 on pruritus symptoms.
To evaluate the effects of ANB020 on quality of life.
Exploratory Objective:
To evaluate the effects of ANB020 on asthma symptoms.
To evaluate the immunogenicity of ANB020.
To characterize the PK of ANB020.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

● Male or female subjects must be 18 to 75 years of age, at the time of
signing the informed consent.
● Body mass index (BMI) of 18 to ≤35 kg/m2 for females and 18 to 40
kg/m2 for males, and total body weight >50 kg (110 lb).
● Clinically confirmed diagnosis of AD.
● Eczema Area and Severity Index (EASI) score ≥16, body surface area
(BSA) involvement ≥10%, and an Investigator's Global Assessment
(IGA) score (5-point scale) ≥3 at baseline.
● Subjects with a history of inadequate response to topical treatment,
use of systemic treatments to treat AD, and/or for whom topical
treatments are otherwise medically inadvisable.
● Daily use of non-medicated emollient for at least 7 days prior to
baseline.
● A WOCB who agrees to follow the contraceptive guidance during the
treatment period and for at least 3 months after receiving the last dose
of study treatment and refrain from donating oocytes (eggs) during this
period.
For additional details refer to the study protocol

E.4

Principal exclusion criteria

● Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
● Prior exposure to an anti-IL-33 antibody.
● Exposure to an investigational or licensed or other anti-Th2-type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer.
● History of prior exposure to any investigational or biologic systemic treatment within 5 half-lives of the screening or is currently enrolled in another clinical study.
● Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.
● History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of this study is percent change in Eczema Area and
Severity Index score (EASI) at Week 16.
The safety and tolerability endpoints of this study are as follows:
Incidence of AEs.
Incidence of SAEs, and AEs leading to withdrawal.
Changes in vital signs (BP, temperature, respiration rate, and HR and
weight).
Changes in clinical safety laboratory tests (hematology, chemistry, and
urinalysis).
Changes in ECG parameters.
Detection of anti-drug antibodies (ADA).

E.5.1.1

Timepoint(s) of evaluation of this end point

Throughout the duration of the study.

E.5.2

Secondary end point(s)

Proportion of subjects who achieve Investigator's Global Assessment (IGA) response of 0 (clear) or 1 (almost clear).
Proportion of subjects who achieve IGA Score reduction of ≥2.
Percent change in peak weekly averaged numerical rating scale (NRS) for pruritus score from baseline.
Proportion of subjects who achieve NRS for pruritus score reduction from baseline of ≥4.
Proportion of subjects with EASI-50 (≥50% improvement from baseline).
Proportion of subjects with EASI-75 (≥75% improvement from baseline).
Percentage change in EASI score from baseline to clinical assessment time points prior to Week 16.
Absolute change in EASI score from baseline.
Percent change in percent Body Surface Area (BSA) from baseline.
Absolute change in percent BSA from baseline.
Percent change in Scoring Atopic Dermatitis (SCORAD) scores from baseline.
Absolute change in SCORAD scores from baseline.
Describe limited pharmacokinetics.

E.5.2.1

Timepoint(s) of evaluation of this end point

Throughout the duration of the study.

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

Canada

Czech Republic

Germany

Poland

United Kingdom

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

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:

285

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

108

F.4.2.2

In the whole clinical trial

300

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)

The subject should be returned to the care of a physician and standard
therapy as required.

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

2018-09-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-12-03

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials