A Study to Learn About the Study Medicine Called Ritlecitinib in People With Hives Without a Known Cause

2025-522642-44-00 Protocol B7981118 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 18 Mar 2026 · Status Ongoing, recruiting · 4 EU/EEA countries · 29 sites · Protocol B7981118

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 150
Countries 4
Sites 29

CHRONIC SPONTANEOUS URTICARIA

To compare the effect of ritlecitinib on improvement in UAS7 at Week 12. To evaluate the safety and tolerability of ritlecitinib in participants with CSU

Key facts

Sponsor
Pfizer Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trial duration
18 Mar 2026 → ongoing
Decision date (initial)
2026-03-02
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001, USA

External identifiers

EU CT number
2025-522642-44-00
ClinicalTrials.gov
NCT07219615

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

To compare the effect of ritlecitinib on improvement in UAS7 at Week 12.

To evaluate the safety and tolerability of ritlecitinib in participants with CSU

Secondary objectives 10

  1. To evaluate the effect of ritlecitinib on improvement in UAS7
  2. To evaluate the effect of ritlecitinib on improvement in itch
  3. To evaluate the effect of ritlecitinib on improvement in hives
  4. To evaluate the effect of ritlecitinib on complete resolution of disease activity/severity
  5. To evaluate the effect of ritlecitinib on participants achieving the minimal residual disease activity/severity
  6. To evaluate the effect of ritlecitinib on complete resolution of itch
  7. To evaluate the effect of ritlecitinib on complete resolution of hives
  8. To evaluate the effect of ritlecitinib on time to achieving minimal residual disease activity/severity
  9. To evaluate the effect of ritlecitinib on time to achieving MCID in UAS7
  10. To evaluate the safety and tolerability of ritlecitinib in participants with CSU

Conditions and MedDRA coding

CHRONIC SPONTANEOUS URTICARIA

VersionLevelCodeTermSystem organ class
20.0 PT 10072757 Chronic spontaneous urticaria 100000004858

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. adults (aged ≥18 years old or minimum legal adult age as defined per local regulation, whichever is greater)
  2. clinical diagnosis of CSU for ≥3 months at the time of screening who remain symptomatic despite treatment with second generation H1-antihistamines (sgAH) (at locally approved dose or higher) and are anti-IgEnaïve or anti-IgE-experienced (who stopped, could not tolerate, or did not adequately respond)

Exclusion criteria 1

  1. Participants will not be eligible if their urticaria is solely due to inducible urticaria, have active dermatological diseases other than CSU with urticaria wheels or angioedema or other skin diseases associated with chronic itching.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Change from baseline in UAS7 at Week 12
  2. Incidence of TEAEs, SAEs, and AEs leading to discontinuation

Secondary endpoints 10

  1. Change from baseline in UAS7 at all timepoints except Week 12
  2. Change from baseline in ISS7 at Week 12
  3. Change from baseline in HSS7 at Week 12
  4. Achieving complete response defined as UAS7=0 at Week 12
  5. Achieving UAS7 ≤6 at Week 12
  6. Achieving complete response defined as ISS7=0 at Week 12
  7. Achieving complete response defined as HSS7=0 at Week 12
  8. Time to achieving UAS7 ≤6
  9. Time to achieving improvement from baseline ≥10 in UAS7
  10. Incidence of TEAEs, SAEs, and AEs leading to discontinuation

Investigational products

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

Test 2

Ritlecitinib tosilate

PRD9906097 · Product

Active substance
Ritlecitinib Tosilate
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
50 mg milligram(s)
Max total dose
8400 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Not Authorised
MA holder
PFIZER INC.
Paediatric formulation
No
Orphan designation
No

Ritlecitinib Tosilate

PRD10739137 · Product

Active substance
Ritlecitinib Tosilate
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
100 mg milligram(s)
Max total dose
16800 mg milligram(s)
Max treatment duration
24 Week(s)
Authorisation status
Not Authorised
MA holder
PFIZER INC.
Paediatric formulation
No
Orphan designation
No

Placebo 2

Placebo for pf-06651600-15, 100 mg

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

Placebo for pf-06651600-15, 50 mg

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

Loratadine

SUB08581MIG · Substance

Active substance
Loratadine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
40 mg milligram(s)
Max treatment duration
34 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Updosing the locally approved dose upto fourfold per the international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

155 Total trials 47 Recruiting 95 Ended
Commercial
Sponsor organisation
Pfizer Inc.
Address
66 Hudson Boulevard East
City
New York
Postcode
10001-2189
Country
United States

Scientific contact point

Organisation
Pfizer Inc.
Contact name
Clinical Medical Lead

Public contact point

Organisation
Pfizer Inc.
Contact name
Clinical Medical Lead

Third parties 5

OrganisationCity, countryDuties
Premier Research International LLC
ORG-100054043
 Morrisville, United States Other
Ppd Inc.
ORG-100018960
 Wilmington, United States Laboratory analysis
York Bioanalytical Solutions Limited
ORG-100037279
 York, United Kingdom Laboratory analysis
Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
ORG-100043119
 Shanghai, China Laboratory analysis
Iqvia Inc.
ORG-100010622
 Durham, United States Other

Locations

4 EU/EEA countries · 29 investigational sites

By country

CountryMS statusPlanned subjectsSites
Bulgaria Ongoing, recruiting 7 7
Germany Ongoing, recruiting 7 7
Poland Ongoing, recruiting 25 8
Spain Authorised, recruiting 7 7
Rest of world
Canada, Japan, Taiwan, United States, Korea, Democratic People's Republic of, China
 — 104 —

Investigational sites

Bulgaria

7 sites · Ongoing, recruiting
Asclepius Medical Center OOD
NA, Ploshtad Svoboda 1, 2600, Dupnitsa
Medical Center Hera EOOD
NA, Ulitsa Klisura 20, 1510, Sofiya
Medical Center Pulmovision Ltd.
NA, Studentski District, Ulitsa Plovdivsko Pole 11, Sofia
Diagnostic Consultative Centre Ascendent EOOD
NA, Ulitsa Bacho Kiro 47, 1202, Sofia
Medical Center Pulmo-2018 EOOD
NA, Bulevard Bulgaria 152 Fl 2, 6300, Haskovo
Diagnostic And Consulting Center 1 Pernik EOOD
NA, Ulitsa Breznik 2, 2300, Pernik
Diagnostic-consultative center “Aleksandrovska” EOOD
NA, Georgi Sofiyski Str 1, 1431, Sofia

Germany

7 sites · Ongoing, recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Klinik und Poliklinik für Dermatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaet Leipzig
Department of Dermatology, Philipp-Rosenthal-Strasse 23, Zentrum-Suedost, Leipzig
Hautarztpraxis Dr. Leitz Und Kollegen
NA, Marienstrasse 1, Mitte, Stuttgart
Helios Universitaetsklinikum Wuppertal
Campus Barmen, Heusnerstrasse 40, Barmen, Wuppertal
Universitaetsklinikum Giessen und Marburg GmbH
NA, Baldingerstrasse 1, 35043, Marburg
Charite Universitaetsmedizin Berlin KöR
Campus Benjamin Franklin, Hindenburgdamm 30, Lichterfelde, Berlin
Universitätsklinikum Münster
NA, Von-Esmarch-Straße 58, 48149, Münster

Poland

8 sites · Ongoing, recruiting
M2M Med. Badania Sp. z o.o.
NA, Ul. Lwowska 34, 41-500, Chorzow
Klinika Osipowicz & Turkowski Sp. z o.o.
NA, Ul. Bartycka 24b/u1, 00-716, Warsaw
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
ALERGO-MED Ośrodek Badań Klinicznych Sp. z o.o., Pck 26 Street, 33-100, Tarnow
Melita Medical Sp. z o.o.
NA, Ul. Strzegomska 2-4, 53-611, Wroclaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
NA, Ul. Na Zaspe 3, 80-546, Gdansk
Trialmed Sp. z o.o.
Trialmed CRS Warszawa, Solipska 27/ Lu 3, 02-482, Warsaw
Etg Warszawa Sp. z o.o.
NA, Ul. Wynalazek 4, 02-677, Warsaw
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
na, Ul. Szafirowa 15/lok 45, 20-573, Lublin

Spain

7 sites · Authorised, recruiting
Clinica Gaias Santiago
Dermatology, Rua Do Pintor Xaime Quesada N 2-4, 15702, Santiago De Compostela
Hospital Arnau De Vilanova De Valencia
Dermatology, Calle De San Clemente 12, 46015, Valencia
Hospital Universitario Y Politecnico La Fe
Dermatology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Reina Sofia
Dermatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Del Mar
Dermatology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Fundacion Alcorcon
Dermatology, Calle Budapest 1, 28922, Alcorcon
Hospital Universitario Miguel Servet
Dermatology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Bulgaria 2026-03-20 2026-04-21
Germany 2026-03-18 2026-04-20
Poland 2026-03-19 2026-04-27
Spain 2026-04-20

Results and documents

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

Documents 36 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_2025-522642-44-00_B7981118_EN_Public 1
Protocol (for publication) D4_Patient-facing material linked to endpoints_2025-522642-44-00_B7981118_BG_copyright 1
Protocol (for publication) D4_Patient-facing material linked to endpoints_2025-522642-44-00_B7981118_DE_copyright 1
Protocol (for publication) D4_Patient-facing material linked to endpoints_2025-522642-44-00_B7981118_EN_copyright 1
Protocol (for publication) D4_Patient-facing material linked to endpoints_2025-522642-44-00_B7981118_ES_copyright 1
Recruitment arrangements (for publication) K1_B7981118_Informed_consent_and_patient_recruitment_arrengements_PL_PL 1
Recruitment arrangements (for publication) K1_B7981118_Informed_consent_patient_recruitment_procedure_ES_EN 1
Recruitment arrangements (for publication) K1_B7981118_Recruitment arrangements_BG_BG 1
Recruitment arrangements (for publication) K1_Recruiment and Informed consent procedure B7981118_DE_EN 1
Recruitment arrangements (for publication) K2_Recruitment Material_B7981118_ site 1009_PL_PL 1
Recruitment arrangements (for publication) K3_Recruitment Material_B7981118_ site 1095_poster_PL_PL 1
Recruitment arrangements (for publication) K4_Recruitment Material_B7981118_ site 1095_leaflet_PL_PL 1
Recruitment arrangements (for publication) K5_Recruitment Material_B7981118_ site 1095_mockuptext_PL_PL 1
Recruitment arrangements (for publication) K6_Recruitment arrangements_B7981118_ site1095_post on socialmedia_PL_PL 2
Recruitment arrangements (for publication) K6b_Recruitment arrangements_B7981118_ site1095_post on socialmedia_PL_PL_TC 2
Subject information and informed consent form (for publication) L1a_ Main ICD B7981118 DE_DE_Public NA
Subject information and informed consent form (for publication) L1a1_ Main ICD_B7981118_ES_ES_Public N/A
Subject information and informed consent form (for publication) L1a1_Main ICD_B7981118_PL_PL_Public na
Subject information and informed consent form (for publication) L1a1_Main_ICF_B7981118_BG_BG_Public N/A
Subject information and informed consent form (for publication) L1a2_Main ICD_B7981118_PL_PL_TC na
Subject information and informed consent form (for publication) L1a2_Main_ICF_B7981118_BG_EN_Public N/A
Subject information and informed consent form (for publication) L1b Scout_ICD_B7981118_DE_DE_Public 1
Subject information and informed consent form (for publication) L1b_Pregnant Partner Release of Information Form_B7981118_ES_ES_Public 1
Subject information and informed consent form (for publication) L1b_Pregnant Partner Release of Information Form_B7981118_PL_PL_Public 1
Subject information and informed consent form (for publication) L1b1_Optional_RRS_ICF_B7981118_BG_BG_Public N/A
Subject information and informed consent form (for publication) L1b2_Optional_RRS_ICF_B7981118_BG_EN_Public N/A
Subject information and informed consent form (for publication) L1c_Optional Procedure Informed Consent_B7981118_PL_PL_Public 1
Subject information and informed consent form (for publication) L1c_Optional Retained Research ICD_B7981118 _ES_ES_Public 1
Subject information and informed consent form (for publication) L1c1_Pregnant Partner Release of Information Form_B7981118_BG_BG_Public N/A
Subject information and informed consent form (for publication) L1c2_Pregnant Partner Release of Information Form_B7981118_BG_EN_Public N/A
Subject information and informed consent form (for publication) L1d_Scout ICD_B7981118_PL_PL_Public 2
Subject information and informed consent form (for publication) L2_Optional RRS ICD B7981118 DE_DE_Public NA
Subject information and informed consent form (for publication) L2c_Optional RRS ICD B7981118 DE_DE 02FEB2026 TC NA
Synopsis of the protocol (for publication) D2_Protocol-Synopsis_2025-522642-44-00_B7981118_BG_public 1
Synopsis of the protocol (for publication) D2_Protocol-Synopsis_2025-522642-44-00_B7981118_ES_public 1
Synopsis of the protocol (for publication) D2_Protocol-Synopsis_2025-522642-44-00_B7981118_PL_public 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-30 Germany Acceptable
2026-02-23
 2026-02-25
2 SUBSTANTIAL MODIFICATION SM-1 2026-04-14 Acceptable 2026-05-25
3 NON SUBSTANTIAL MODIFICATION NSM-1 2026-05-30 Acceptable
2026-02-23
 2026-05-30
4 NON SUBSTANTIAL MODIFICATION NSM-2 2026-05-30 Acceptable
2026-02-23
 2026-05-30
5 NON SUBSTANTIAL MODIFICATION NSM-3 2026-06-01 Acceptable
2026-02-23
 2026-06-01

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