Clinical Trials Register

Summary
EudraCT Number:	2022-003361-37
Sponsor's Protocol Code Number:	C5041005
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-12-20
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

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2022-003361-37

A.3

Full title of the trial

A PHASE 2/3, TWO-PART STUDY TO EVALUATE THE EFFICACY AND LONG-TERM SAFETY WITH ORAL ETRASIMOD, 2 MG, ONCE DAILY IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS WITH A HISTORY OF PRIOR SYSTEMIC TREATMENT FAILURE

STUDIE FÁZE 2/3, ROZDĚLENÁ NA DVĚ ČÁSTI, HODNOTÍCÍ ÚČINNOST A DLOUHODOBOU BEZPEČNOST PERORÁLNÍHO PŘÍPRAVKU ETRASIMOD V DÁVCE 2 MG JEDNOU DENNĚ U DOSPĚLÝCH ÚČASTNÍKŮ SE STŘEDNĚ TĚŽKOU AŽ TĚŽKOU FORMOU ATOPICKÉ DERMATITIDY S ANAMNÉZOU PŘEDCHOZÍHO SELHÁNÍ SYSTÉMOVÉ LÉČBY

A.3.1

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

A Study of Etrasimod in Adults With Moderate-to-Severe Atopic Dermatitis, Who Have Tried Prior Systemic Treatments for Atopic Dermatitis.

Studie přípravku Etrasimod u dospělých se středně těžkou až těžkou formou atopické dermatitidy, kteří dříve selhali na systémové léčbě atopické dermatitidy

A.4.1

Sponsor's protocol code number

C5041005

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT05732454

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	Pfizer 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	Pfizer 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	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	66 Hudson Boulevard East
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10001
B.5.3.4	Country	United States
B.5.4	Telephone number	18007181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.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	etrasimod
D.3.2	Product code	PF-07915503
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	etrasimod
D.3.9.2	Current sponsor code	PF-07915503
D.3.9.3	Other descriptive name	Etrasimod arginine
D.3.9.4	EV Substance Code	SUB283786
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	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	Tablet
D.8.4	Route of administration of the placebo	Oral 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 with a History of Prior Systemic Treatment Failure

E.1.1.1

Medical condition in easily understood language

Atopic Dermatitis

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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	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

-Part 1 DB: To evaluate the efficacy of etrasimod, 2 mg, QD versus placebo in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure.
-Part 1 OLE and Part 2 (OL): To evaluate the long-term safety of oral etrasimod, 2 mg, QD in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure.

E.2.2

Secondary objectives of the trial

-Part 1 DB: To evaluate the efficacy of etrasimod, 2 mg, QD based on additional measures in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure.
-Part 1 OLE and Part 2: To evaluate the long-term efficacy of oral etrasimod, 2 mg, QD in adult participants with moderate-to-severe AD and a history of a prior systemic therapy failure.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening).
2.Moderate to severe AD:
a.IGA score ≥3 (on the 0 to 4 IGA scale, in which 3 = moderate and 4 = severe) at screening and baseline (Day 1)
b.BSA ≥10% of AD involvement at screening and baseline (Day 1)
c.Eczema Area and Severity Index (EASI) ≥16 at screening and baseline (Day 1)
3.A participant who has failed a prior systemic therapy for AD, ie, refractory, moderate-to-severe AD that is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. (i.e., medical contraindications to systemic therapy prohibit use).
a.Inadequate response to ≥ 2 weeks of cyclosporine, azathioprine, methotrexate, mycophenolate, biologic, JAK inhibitors, or systemic corticosteroid (CS; defined as pulse of systemic CS or ≥ 2 weeks of continuous oral CS), or when systemic therapy is inadvisable.
- In Part 1, approximately 30% of participants are permitted with a failure of a prior systemic corticosteroid therapy without failing another systemic treatment for AD. For the remaining participants, failure of a prior systemic corticosteroid therapy alone is not sufficient to meet the criterion of prior systemic failure, i.e., the participant must fail another systemic treatment for AD.
- In Part 2, failure of systemic corticosteroids may qualify a participant for the study.
b.Refractory is an insufficient clinical response defined as the inability to achieve and maintain remission or a low disease activity state of minimal or mild lesions only, within 1 year of screening, despite treatment with systemic therapy for a period sufficient to demonstrate efficacy as determined by the Investigator.
c.Acceptable documentation for these criteria includes chart notes that record medication prescription and treatment outcome, or Investigator documentation based on communication with the patient's treating physician. For study purposes, document failure of prior systemic drug(s) to adequately control AD in the CRF.
4.Willing to apply a topical emollient/moisturizer at least once daily for ≥1 week prior to baseline (Day 1) and willing to maintain consistent (ie, no change in type, frequency, or application) daily application over the course of the study.

E.4

Principal exclusion criteria

1.Presence of potential confounding factors:
-Skin conditions (eg, psoriasis, seborrheic dermatitis) that may interfere with evaluation of AD or assessment of treatment response as deemed by the Investigator.
-Current significant active infection or requiring a treatment for infection that may interfere with the assessment of AD.
Study Arms and Duration:
Part 1 (DB period and OLE period):
-Etrasimod, 2 mg (tablet) QD for 16 weeks or Placebo (tablet) QD for 16 weeks; OLE period: Etrasimod, 2 mg (tablet) QD for 52 weeks.
-Up to 76 weeks duration: including up to 4 weeks for screening, 16-week DB treatment period, 52-week OLE treatment period, and a safety follow-up at 2 and 4 weeks after treatment completion.
Part 2 (OL period):
-Etrasimod, 2 mg (tablet) QD for 52 weeks.
-Up to 60 weeks duration: including up to 4 weeks for screening, 52-week OL treatment period, and a safety follow-up at 2 and 4 weeks after treatment completion.

E.5 End points

E.5.1

Primary end point(s)

- Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline at Week 16.
- Incidence and severity of treatment-emergent AEs, AEs leading to study treatment discontinuation, SAEs, and AESIs.
-Incidence of clinically significant changes in clinical laboratory values, ECG measurements and vital signs.

E.5.1.1

Timepoint(s) of evaluation of this end point

- At Week 16
- Throughout the study

E.5.2

Secondary end point(s)

-Proportion of participants achieving a EASI-75 at Week 16.
-Percent change from baseline in EASI at Week 16.

E.5.2.1

Timepoint(s) of evaluation of this end point

16 weeks

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

E.6.7

Pharmacodynamic

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

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)

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

open label

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

Yes

E.8.2.3.1

Comparator description

open label

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

Mexico

United States

Bulgaria

Czechia

France

Germany

Italy

Poland

Spain

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:

388

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

163

F.4.2.2

In the whole clinical trial

400

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)

No study intervention will be provided to participants at the end of their study participation. It is expected that participants will be treated as required with standard-of-care treatments, as advised by their usual care physician.

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

2023-03-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-01-25

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

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