This is a clinical trial (study), to be conducted at multiple clinical sites, of an oral study drug (EP262) that will be investigated in adult participants with Chronic Spontaneous Urticaria (CSU) to assess if it is effective and safe.

2023-504799-94-00 Protocol EP-262-201 Therapeutic exploratory (Phase II) Ended

Start 20 Feb 2024 · End 4 Mar 2025 · Status Ended · 4 EU/EEA countries · 16 sites · Protocol EP-262-201

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 154
Countries 4
Sites 16

Chronic Spontaneous Urticaria

To evaluate the efficacy of EP262 compared to placebo in participants with CSU.

Key facts

Sponsor
Escient Pharmaceuticals Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trial duration
20 Feb 2024 → 4 Mar 2025
Decision date (initial)
2023-12-28
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Escient Pharmaceuticals, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of EP262 compared to placebo in participants with CSU.

Secondary objectives 2

  1. To evaluate the safety and tolerability of EP262 compared to placebo in participants with CSU.
  2. To evaluate the efficacy of EP262 compared to placebo in participants with CSU.

Conditions and MedDRA coding

Chronic Spontaneous Urticaria

VersionLevelCodeTermSystem organ class
20.0 PT 10072757 Chronic spontaneous urticaria 100000004858

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Phase 2 Double-blind Treatment Period
The total duration of subject participation will be up to 14 weeks comprising a screening period of approximately 2 to 4 weeks, a 6-week study treatment period, and a 4-week follow-up period after the last dose of the study drug
 Randomised Controlled Double [{"id":101121,"code":3,"name":"Monitor"},{"id":101123,"code":1,"name":"Subject"},{"id":101122,"code":2,"name":"Investigator"}] Arm 1: Two oral capsule of EP262 25 mg once daily
Arm 2: Two oral capsule of EP262 75 mg once daily
Arm 3: Two oral capsules of placebo once daily
Arm 4: One oral capsule of EP262 25 mg once daily
Arm 5: One oral capsule of placebo once daily

Regulatory references

Scientific advice from competent authorities
Federal Institute For Drugs And Medical Devices
Plan to share IPD
No
EU CT numberTitleSponsor
2023-504800-28-00 Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects with Chronic Inducible Urticaria Escient Pharmaceuticals Inc.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Age 18 to 80 years
  2. Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care
  3. Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines

Exclusion criteria 3

  1. Urticaria with a clear underlying etiology other than CSU
  2. Urticaria with a clearly defined or sole trigger (chronic inducible urticaria)
  3. Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The change in both itch intensity and number of hives.

Secondary endpoints 4

  1. Type, frequency, and severity of side effects related to the treatment.
  2. Change in vital signs, electrocardiograms (ECGs), and clinical laboratory parameters.
  3. Change in itch intensity.
  4. Change in number of hives.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

EP262

PRD10480971 · Product

Active substance
EP262
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
150 mg milligram(s)
Max total dose
6300 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Not Authorised
MA holder
ESCIENT PHARMACEUTICALS, INC.
Paediatric formulation
No
Orphan designation
No

EP262

PRD10480970 · Product

Active substance
EP262
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
2100 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Not Authorised
MA holder
ESCIENT PHARMACEUTICALS, INC.
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 1

-

R06A · Product

Pharmaceutical form
-
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
R06A — ANTIHISTAMINES FOR SYSTEMIC USE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Escient Pharmaceuticals Inc.

2 Total trials 2 Ended
Commercial
Sponsor organisation
Escient Pharmaceuticals Inc.
Address
10578 Science Center Drive Suite 250
City
San Diego
Postcode
92121-1147
Country
United States

Scientific contact point

Organisation
Escient Pharmaceuticals Inc.
Contact name
Clinical Trial Information

Public contact point

Organisation
Escient Pharmaceuticals Inc.
Contact name
Clinical Trial Information

Third parties 18

OrganisationCity, countryDuties
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Bioagilytix Labs LLC
ORG-100013030
 Boston, United States Laboratory analysis
Clario
ORL-000001443
 United States Other
Almac Clinical Services LLC
ORG-100041692
 Souderton, United States Code 14
Azenta US Inc.
ORG-100016263
 Indianapolis, United States Laboratory analysis
Mayo Collaborative Services LLC
ORG-100046687
 Rochester, United States Laboratory analysis
Eurofins Viracor Biopharma Services Inc.
ORG-100041736
 Lenexa, United States Laboratory analysis
Medrio Inc.
ORG-100045869
 San Francisco, United States E-data capture
LabConnect Europe B.V.
ORG-100047701
 Swalmen, Netherlands Other
Rules Based Medicine Inc.
ORG-100043610
 Austin, United States Laboratory analysis
Transperfect Translations International Inc.
ORG-100043494
 New York, United States Other
Innovaderm Research Inc.
ORG-100044152
 Montreal, Canada On site monitoring, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, Code 8, Code 9
Charite Universitaetsmedizin Berlin KöR
ORG-100008480
 Berlin, Germany Laboratory analysis
National Jewish Health
ORG-100043431
 Denver, United States Laboratory analysis
LabConnect GmbH
ORG-100047696
 Cologne, Germany Other, Laboratory analysis
Almac Clinical Service Limited
ORL-000001918
 Craigavon, United Kingdom Code 14, Interactive response technologies (IRT)
Arup Laboratories Inc.
ORG-100041750
 Salt Lake City, United States Laboratory analysis
Celerion Inc.
ORG-100029202
 Lincoln, United States Laboratory analysis

Locations

4 EU/EEA countries · 16 investigational sites

By country

CountryMS statusPlanned subjectsSites
Germany Ended 6 4
Netherlands Ended 5 1
Poland Ended 25 8
Spain Ended 8 3
Rest of world
United States, Canada
 — 110 —

Investigational sites

Germany

4 sites · Ended
Technische Universitat Dresden
Dermatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz Koerperschaft Des Offentlichen Rechts
Dermatology, Langenbeckstrasse 1, Oberstadt, Mainz
Medizinische Hochschule Hannover
Dermatology, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Charite Universitaetsmedizin Berlin KöR
Dermatology, Hindenburgdamm 30, Lichterfelde, Berlin

Netherlands

1 site · Ended
Centre for Human Drug Research
Dermatology, Zernikedreef 8, 2333 CL, Leiden

Poland

8 sites · Ended
EMC Instytut Medyczny S.A.
N/A, Ul. Grunwaldzka 156, 60-309, Poznan
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Dermatology, Ul. Woloska 137, 02-507, Warsaw
Prywatna Praktyka Lekarska Ewa Ring
Dermatology, Solipska 27/LU-3, 02-482, Warszawa
Gyncentrum Sp. z o.o.
N/A, Ul. Jozefa Mehoffera 10, 31-322, Cracow
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Dermatology, Ul. Na Zaspe 3, 80-546, Gdansk
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
N/A, Ul Mieczyslawa Niedzialkowskiego 10a/50, 61-578, Poznan
Medicome Sp. z o.o.
N/A, Plac Tadeusza Kosciuszki 12, 32-600, Oswiecim
Gyncentrum Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 229, 40-600, Katowice

Spain

3 sites · Ended
Hospital Arnau De Vilanova De Valencia
Dermatology, Calle De San Clemente 12, 46015, Valencia
Hospital Del Mar
Dermatology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Clinico San Carlos
Dermatology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2024-03-05 2024-03-05 2024-11-13
Netherlands 2024-05-28 2024-11-13 2024-05-28 2024-11-13
Poland 2024-02-20 2024-02-20 2024-11-13
Spain 2024-04-09 2024-04-09 2024-11-13

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
Technical Results Summary 2023-504799-94
SUM-107763
 2025-11-24T14:50:40 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
Plain Language Summary of Results 2023-504799-94_eng 2025-11-24T14:51:30 Submitted Laypersons Summary of Results
Plain Language Summary of Results 2023-504799-94_de 2025-11-24T14:51:17 Submitted Laypersons Summary of Results
Plain Language Summary of Results 2023-504799-94_pl 2025-11-24T14:51:04 Submitted Laypersons Summary of Results
Plain Language Summary of Results 2023-504799-94_es 2025-11-24T14:50:56 Submitted Laypersons Summary of Results
Plain Language Summary of Results 2023-504799-94_nl 2025-11-24T14:50:49 Submitted Laypersons Summary of Results

Documents 141 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Plain Language Summary of Results 2023-504799-94_de 1
Laypersons summary of results (for publication) Plain Language Summary of Results 2023-504799-94_eng 1
Laypersons summary of results (for publication) Plain Language Summary of Results 2023-504799-94_es 1
Laypersons summary of results (for publication) Plain Language Summary of Results 2023-504799-94_nl 1
Laypersons summary of results (for publication) Plain Language Summary of Results 2023-504799-94_pl 1
Protocol (for publication) D1_Protocol 2023-504799-94_For Publication 4.0
Protocol (for publication) D4_Patient facing documents_Protocol Appendix C_DE_German 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix C_ES_Spanish 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix C_NL_Dutch 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix C_PL_Polish 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix D_DE_German_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix D_ES_Spanish_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix D_NL_Dutch_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix D_PL_Polish_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix E_DE_German_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix E_ES_Spanish_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix E_NL_Dutch_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix E_PL_Polish_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix F_DE_German_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix F_ES_Spanish_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix F_NL_Dutch_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix F_PL_Polish_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix G_DE_German_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix G_ES_Spanish_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix G_NL_Dutch_black box 1
Protocol (for publication) D4_Patient facing documents_Protocol Appendix G_PL_Polish_black box 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_PL 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Advertisement Document 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Advertisement Document 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Advertisement Document 2.1
Recruitment arrangements (for publication) K2_Recruitment material_Advertisements 3.0
Recruitment arrangements (for publication) K2_Recruitment material_BannerAds 1.1
Recruitment arrangements (for publication) K2_Recruitment material_BannerAds 1
Recruitment arrangements (for publication) K2_Recruitment material_BannerAds 1
Recruitment arrangements (for publication) K2_Recruitment material_Doctor to Patient_Letter 1
Recruitment arrangements (for publication) K2_Recruitment material_Doctor to Patient_Letter 1
Recruitment arrangements (for publication) K2_Recruitment material_Doctor to Patient_Letter 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1
Recruitment arrangements (for publication) K2_Recruitment material_Online PreScreener 1
Recruitment arrangements (for publication) K2_Recruitment material_Online PreScreener 1
Recruitment arrangements (for publication) K2_Recruitment material_Online PreScreener 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Brochure 1
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Recruitment arrangements (for publication) K2_Recruitment material_Poster 1
Recruitment arrangements (for publication) K2_Recruitment material_Poster 1
Recruitment arrangements (for publication) K2_Recruitment material_Website text Popup 1
Recruitment arrangements (for publication) K2_Recruitment material_Website text Popup 1
Recruitment arrangements (for publication) K2_Recruitment material_Website text Popup 1
Recruitment arrangements (for publication) K2_Recruitment material_WebsiteContent 3.1
Recruitment arrangements (for publication) K2_Recruitment material_WebsiteContent 3.0
Recruitment arrangements (for publication) K2_Recruitment material_WebsiteContent 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Part 2_Redacted 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Part 2_redacted 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Part 2_Redacted 4.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Redacted 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF Personal data processing_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy and Newborn Follow-up 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy and Newborn Follow-up_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy and Newborn Follow-up_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy and Newborn Follow-up_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner and Newborn Follow-up_Redacted 3.0
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Subject information and informed consent form (for publication) L10_Tablet training module_eCOA tablet screenshot 1
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Subject information and informed consent form (for publication) L12_Other subject information material_ClinCard ICF_Redacted 2.0
Subject information and informed consent form (for publication) L12_Other subject information material_ClinCard ICF_Redacted 2.1
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Subject information and informed consent form (for publication) L15_Other subject information material_ClinCard Cardholder Msg Templates_Redacted 10.0
Subject information and informed consent form (for publication) L16_Other subject information material_i2c EU Dispute Form_Redacted 10.0
Subject information and informed consent form (for publication) L16_Other subject information material_i2c EU Dispute Form_Redacted 10.0
Subject information and informed consent form (for publication) L16_Other subject information material_i2c EU Dispute Form_Redacted 10.0
Subject information and informed consent form (for publication) L17_Other subject information material_ClinCard_Fee_Schedule_Redacted 10.1
Subject information and informed consent form (for publication) L17_Other subject information material_ClinCard_Fee_Schedule_Redacted 10.1
Subject information and informed consent form (for publication) L17_Other subject information material_ClinCard_Fee_Schedule_Redacted 10.1
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Subject information and informed consent form (for publication) L18_Other subject information material_ClinCard_Generic_Image_Redacted 10.0
Subject information and informed consent form (for publication) L2_Other subject information material_Participant Emergency Card 1
Subject information and informed consent form (for publication) L2_Other subject information material_Participant Emergency Card 1
Subject information and informed consent form (for publication) L2_Other subject information material_Participant Emergency Card 1
Subject information and informed consent form (for publication) L2_Other subject information material_Participant Emergency Card 1
Subject information and informed consent form (for publication) L3_Other subject information material_Leaflet_Subject Dosing Instructions 1
Subject information and informed consent form (for publication) L3_Other subject information material_Leaflet_Subject Dosing Instructions 1
Subject information and informed consent form (for publication) L3_Other subject information material_Leaflet_Subject Dosing Instructions 1
Subject information and informed consent form (for publication) L3_Other subject information material_Patient card 1
Subject information and informed consent form (for publication) L4_Dosing diary_eCOA handheld screenshot 1
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Subject information and informed consent form (for publication) L4_Dosing diary_eCOA handheld_Part 2 2.2
Subject information and informed consent form (for publication) L4_Dosing diary_eCOA handheld_Part 2 2.2
Subject information and informed consent form (for publication) L4_Dosing diary_eCOA handheld_Part 2 2.2
Subject information and informed consent form (for publication) L5_Handheld complete_eCOA handheld screenshot 1
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Subject information and informed consent form (for publication) L8_Participant training video script_Redacted 2.0
Subject information and informed consent form (for publication) L8_Participant training video script_Redacted 2.0
Subject information and informed consent form (for publication) L8_Participant training video script_Redacted 2.0
Subject information and informed consent form (for publication) L8_Participant training video script_Redacted 2.0
Subject information and informed consent form (for publication) L9_Tablet complete_eCOA tablet screenshot 1
Subject information and informed consent form (for publication) L9_Tablet complete_eCOA tablet screenshot 1
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Subject information and informed consent form (for publication) L9_Tablet complete_eCOA tablet screenshot 1
Summary of results (for publication) Technical Results Summary 2023-504799-94 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_DE_2023-504799-94_For Publication 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2023-504799-94_For Publication 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_NL_2023-504799-94_For Publication 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL_2023-504799-94_For Publication 3.0

Application history

7 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-09-13 Germany Acceptable
2023-12-20
 2023-12-28
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-01-30 Acceptable
2023-12-20
 2024-01-30
3 SUBSTANTIAL MODIFICATION SM-1 2024-02-16 Germany Acceptable
2024-03-28
 2024-03-28
4 SUBSTANTIAL MODIFICATION SM-2 2024-04-17 Germany Acceptable
2024-06-20
 2024-06-20
5 SUBSTANTIAL MODIFICATION SM-3 2024-08-30 Germany Acceptable
2024-10-24
 2024-10-25
6 NON SUBSTANTIAL MODIFICATION NSM-4 2024-12-11 Germany Acceptable
2024-10-24
 2024-12-11
7 SUBSTANTIAL MODIFICATION SM-4 2024-12-12 Germany Acceptable
2025-02-07
 2025-02-07

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