A study to evaluate the effectiveness and safety of ritlecitinib tosilate and loratadine in adults with chronic spontaneous urticaria (hives)

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What is this study about?

This study is being conducted to evaluate the safety and effectiveness of the drug ritlecitinib, also known as PF 06651600, in adults living with Chronic Spontaneous Urticaria. This condition is commonly known as hives, which are itchy red welts on the skin that appear without an obvious cause. Some participants may also take loratadine, an antihistamine used to manage allergy symptoms, as part of their regular care.

During the study, participants are assigned to receive either ritlecitinib or a placebo. The study is organized in two stages. The first stage lasts for 12 weeks, after which a second stage, known as an extension period, also lasting 12 weeks, begins. All participants in this phase will follow the same treatment process to see how the medicine affects the severity of the hives over time.

Who Can Join the Study?

  • You must be an adult, which means you are 18 years old or older.
  • You must have a diagnosis of chronic spontaneous urticaria, which is a condition where a person gets hives (itchy, red bumps on the skin) for a long period of time without an obvious cause.
  • Your symptoms must have lasted for at least 3 months.
  • Your symptoms must still be active even though you are taking second-generation H1-antihistamines, which are common allergy medications used to reduce itching and swelling.
  • You must have either never used or have previously stopped using anti-IgE treatments, which are specific types of medicine used to target certain parts of the immune system.

Who Cannot Join the Study?

  • You cannot join the study if your hives are only caused by inducible urticaria, which means hives that are triggered by specific physical factors like pressure, temperature, or sunlight.
  • You are not eligible if you have any other active dermatological diseases, which are medical conditions affecting the skin, that cause skin swelling or hives.
  • You cannot participate if you have other skin conditions that cause chronic itching, which is a continuous or long-lasting sensation that makes you want to scratch your skin.
  • You will be excluded if you have angioedema, which is a type of swelling that occurs deep under the skin, often around the eyes, lips, or hands.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
M2m Med. Sp. z o.o. Chorzow Poland
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Hospital Del Mar Barcelona Spain
Asclepius Medical Center OOD Dupnitsa Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Medical Center Pulmo-2018 EOOD Haskovo Bulgaria
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
Etg Neuroscience Sp. z o.o. Warsaw Poland
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Melita Medical sp. z o.o. Wroclaw Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Klinika Osipowicz & Turkowski Sp. z o.o. Warsaw Poland
Difhwwnlae Aax Csbktolgfb Cbvjzh 1 Prvrnb Eiwo Pernik Bulgaria
Ctwkrop Bmfvr Khjqmjvkbxj Pxtxjduc Snt z opkf Gdansk Poland
Mtapeyl Cpfxjj Povvfpqdjwg Loyc Sofia Bulgaria
Texlnljy Sph z owcj Piotrkow Trybunalski Poland
Uztoaonmgazmdffmfszgf Mvaiumah Acq Munster Germany
Liyeukf Sbdlkassijzkfgz Govglpq Drvdidtuvgxqxhd Lublin Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
16.03.2026
Germany Germany
Recruiting
16.03.2026
Poland Poland
Recruiting
16.03.2026
Spain Spain
Recruiting
16.03.2026

Trial locations

Investigated drugs:

Ritlecitinib is the experimental medication being tested in this study to see if it can help improve symptoms for adults living with chronic spontaneous urticaria (hives).

Loratadine is an antihistamine used as background medication to help manage allergy-like symptoms.

Investigated diseases:

Chronic spontaneous urticaria – This condition is characterized by the repeated appearance of itchy, raised welts on the skin. These welts, often called hives, can occur without any obvious external trigger. The condition is considered chronic when these episodes happen frequently over a long period. The skin may also experience sensations of stinging or burning. As the condition progresses, the frequency and severity of the hives may change over time.

Trial ID:
2025-522642-44-00
Protocol code:
B7981118
NCT ID:
NCT07219615
Trial Phase:
Therapeutic exploratory (Phase II)

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