ICH GCP - EU Clinical trials Registry - 2022-001528-14 (DE)

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Summary
EudraCT Number:	2022-001528-14
Sponsor's Protocol Code Number:	67484703ADM2001
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2023-01-06
Trial 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

A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2022-001528-14

A.3

Full title of the trial

A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-67484703 in Participants with Atopic Dermatitis

A.3.1

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

A Study of JNJ-67484703 in the Treatment of Participants with Moderate to Severe Atopic Dermatitis

A.4.1

Sponsor's protocol code number

67484703ADM2001

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	Janssen-Cilag International NV
B.1.3.4	Country	Belgium
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	Janssen Research & Development, LLC
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	Janssen-Cilag International NV
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.6	E-mail	ClinicaltrialsEU@its.jnj.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	JNJ-67484703
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	None
D.3.9.2	Current sponsor code	JNJ-67484703
D.3.9.3	Other descriptive name	JNJ-67484703
D.3.9.4	EV Substance Code	SUB199415
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	150
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

Atopic Dermatitis

E.1.1.1

Medical condition in easily understood language

An itchy inflammation of the skin

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10003639
E.1.2	Term	Atopic dermatitis
E.1.2	System Organ Class	100000004858

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 evaluate the efficacy of JNJ-67484703 in patients with moderate to severe AD

E.2.2

Secondary objectives of the trial

The secondary objectives are:
• To characterize additional efficacy of JNJ-67484703 in participants with moderate to severe AD.
• To assess the safety and tolerability of JNJ-67484703 in participants with moderate to severe AD.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Be ≥18 years (or the legal age of consent in the jurisdiction in which the study is taking place).
2. Be otherwise healthy on the basis of physical examination and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
3. Have a diagnosis of Atopic Dermatitis for at least 12 months (365 days) before the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history.
4. Have an EASI score ≥16 at screening and at baseline.
5. Have a vIGA-AD score of ≥3 at screening and at baseline.
6. Have a body surface area ≥ 10 at screening and at baseline.
7. Must have a body weight in the range of 50 to 180 kg inclusive.

E.4

Principal exclusion criteria

20.Has received any of the following treatments within 4 weeks before the baseline visit or any condition that in the opinion of the investigator, is likely to require such treatment during the first 4 weeks of study treatment:
•Immunosuppressive/ immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-gamma, systemic Janus kinase inhibitors, azathioprine, methotrexate, etc)
•Phototherapy for AD
21.Has previously received treatment with biologics as follows:
•an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
•Dupilumab
•an immunomodulating biologic within 12 weeks of the baseline visit, or 5 half-lives (if known), whichever is longer (including, but not limited to, anti cytokine, anticomplement antibodies, anti-Ig antibodies, etc).
•any cell-depleting agents including but not limited to rituximab; within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer
•Other biologics: within 5 half-lives if known or 16 weeks before the baseline visit
22.Initiation of treatment of AD during screening with any prescription moisturizers or moisturizers containing additives such as ceramides, hyaluronic acid, urea, or filaggrin degradation products during the screening period (see Section 6.8.4) Patients may continue using stable doses of such moisturizers if initiated before the screening visit.
23.Treatment with TCS, TCI, topical crisaborole, or topical janus kinase inhibitor within 1 week before the baseline visit.
24.Has ever received any PD-1 agonist (Rosnilimab, LY3462817, etc)

E.5 End points

E.5.1

Primary end point(s)

1. Proportion of participants with EASI-75 (≥75% improvement from baseline)

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Week 12

E.5.2

Secondary end point(s)

1. Proportion of participants with improvement (reduction) of eczema-related itch NRS ≥4 from baseline among participants with a baseline itch value ≥4.
2. Proportion of participants with both vIGA-AD of 0 to 1 and a reduction from baseline of ≥2 points.
3. Proportion of participants with EASI-90 (≥90% improvement from baseline).
4. Percentage change in EASI score from baseline.
5. Percent change from baseline of eczema related itch score (item 2 on ESPI NRS).
6. Number/proportion of participants with treatment-emergent AEs.
7. Number/proportion of participants with treatment-emergent SAEs.

E.5.2.1

Timepoint(s) of evaluation of this end point

1-4. Week 12
5. Week 1, 4 and 6
6-7. Throughout 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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability, Biomarker analysis, and Immunogenicity

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

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

Poland

Germany

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

The end of study is considered as the last scheduled Week 36 study assessment for the last participant in the study.

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:

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

F.4.2.2

In the whole clinical trial

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)

Standard of Care

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

2023-01-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-02

P. End of Trial
P.	End of Trial Status	Ongoing

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