Clinical Trials Register

Summary
EudraCT Number:	2019-002495-13
Sponsor's Protocol Code Number:	J1B-MC-FRCF
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-11-05
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

Germany - PEI

A.2

EudraCT number

2019-002495-13

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Crossover Study to Evaluate the Efficacy and Safety of LY3454738 in Adults with Chronic Spontaneous Urticaria Inadequately Controlled with H1-Antihistamines

A.3.1

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

A study to evaluate Efficacy and Safety of LY3454738 in Adults with Chronic Spontaneous Urticaria

A.4.1

Sponsor's protocol code number

J1B-MC-FRCF

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 & 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 & 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 & Company
B.5.2	Functional name of contact point	Clinical Trial Registry Office
B.5.3	Address:
B.5.3.1	Street Address	Lilly Corporate Center, DC 1526
B.5.3.2	Town/ city	Indianapolis
B.5.3.3	Post code	IN 46285
B.5.3.4	Country	United States
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.3.2	Product code	LY3454738
D.3.4	Pharmaceutical form	Lyophilisate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LY3454738
D.3.9.3	Other descriptive name	LY3454738
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	75
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 infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Spontaneous Urticaria

E.1.1.1

Medical condition in easily understood language

Chronic spontaneous urticaria (CSU) is a distressing skin condition that causes red, swollen, itchy and sometimes painful hives or “wheals” on the skin.

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10072757
E.1.2	Term	Chronic spontaneous urticaria
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

To test the hypothesis that treatment with LY3454738 is superior to placebo as measured
by patient-assessed itch severity and hive count for the treatment of adult participants with CSU

E.2.2

Secondary objectives of the trial

- To compare the efficacy of LY3454738 to placebo as measured by improvement in signs and symptoms of CSU
- To characterize the pharmacokinetics (PK) of LY3454738

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

--Are male or female participants from 18 to 65 years of age, inclusive, at the time of
signing the informed consent document.
--Have a diagnosis of CSU for at least 6 months before the screening visit.
--Are taking an approved 24-hour oral dose of a second-generation H1-antihistamine for CSU for at least 10 consecutive days before the baseline visit, and agree to continue taking this medication at the same dose every day throughout the study.
--Have an urticaria activity score during a 7-day period (UAS7 score) of 16 or more during the 7 consecutive days prior to the baseline visit.

E.4

Principal exclusion criteria

--Have a clearly defined underlying cause for chronic urticaria other than
CSU. Such causes can include, but are not limited to, the following:
symptomatic dermatographism (urticaria factitia); cold-, heat-, solar-,
pressure-, delayed pressure-, aquagenic-, cholinergic-, or contacturticaria.
--Have diseases, other than chronic urticaria, with urticarial or
angioedema symptoms. These diseases include, but are not limited to,
urticarial vasculitis, urticaria pigmentosa, erythema multiforme,
mastocytosis, hereditary, or acquired angioedema (for example, due to
C1 inhibitor deficiency), lymphoma, leukemia, or generalized
malignancy.
--Have any other skin disease associated with chronic itching that, in the
investigator's opinion, might influence the study evaluations and results
(including, but not limited to, prurigo nodularis, atopic dermatitis,
bullous pemphigoid, dermatitis herpetiformis, and senile pruritus).--
Have a current or recent acute, active infection.
--Have had, within 6 months of screening, any of the following types of
infection:
Serious infections (requiring hospitalisation, and/or IV or equivalent
intravenous antibiotic treatment),
Opportunistic infections
Chronic infections (duration of symptoms, signs, and/or treatment of 6
weeks or longer),
Recurring infection (including, but not limited to, herpes simplex, herpes
zoster, recurring cellulitis, chronic osteomyelitis).
--Have human immunodeficiency virus (HIV) infection.
--Have a current or past infection with hepatitis B virus (HBV) (that is,
positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core
antibody)
--Have a current infection with hepatitis C virus (HCV) (that is, positive
for HCV ribonucleic acid [RNA])

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the change in UAS7 score from baseline to Week 12 in Period 2, defined as the Week 12 UAS7 score minus the baseline UAS7 score.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 12

E.5.2

Secondary end point(s)

--Change from baseline in ISS7 at Week 12 is the Week 12 ISS7 score minus the baseline ISS7 score.
--Change from baseline in HSS7 at Week 12 is the Week 12 HSS7 score minus the baseline HSS7 score.
--The proportions of participants who achieve a UAS7 score ≤6 at Week 12 will be presented for each treatment group. Participants will be classified as nonresponders at Week 12 (that is, did not achieve UAS7 ≤6 at Week 12) if they have a missing UAS7 score at Week 12.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 12

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

Yes

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

E.8.1.6

Cross over

Yes

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

Germany

Poland

United States

E.8.7

Trial has a data monitoring committee

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

A participant is considered to have completed the study if he or she has completed all required phases of the study including the last visit or the last scheduled procedure shown in the Schedule of Activities. The end of the study is defined as the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last participant in the trial globally.

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:

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)

After the end of participation in the trial the patients will get treated at physician's choice.

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

2020-02-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2020-11-24

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