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
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
M2m Med. Sp. z o.o. Chorzow Poland

Other Sites

Site Name City Country Status
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Hospital Del Mar Barcelona Spain
Muwyvmx Clifwj Pezdamdfbsj Lyzj Sofia Bulgaria
Mqthrdf Cuiclq Hfuo Etya Sofia Bulgaria
Dyzzaqynwrpgjzkbkkgukhw crptpy “zibsqmnkbtlfujn Eqng Sofia Bulgaria
Cqhszsp Ukzahgorsoiqwfomjpwx Bysiuc Kvl Berlin Germany
Urznqsacogtwnevhbguth Msvlzsqz Ara Munster Germany
Jytpspxhvedcxuwpajsmrrforg Gqyxcbf Giessen Germany
Urehptctciof Lbtgpip Leipzig Germany
Crzjlxc Biyoj Kvhbdxhlqfi Pftwjnks Sgh z ouqh Gdansk Poland
Csvrgsz Gmtpp Svvklkms Santiago De Compostela Spain
Egb Ngleeablpcnk Sso z oner Warsaw Poland
Dykxohgdhk Cblfvcbenqkg Cxgzwj Atneeavuo Ogm Sofia Bulgaria
Ahjachbipf Skkglxdnakxznxg Piotmxnipch Lyymlacs Scj z ofbt Tarnow Poland
Lkfgisk Sxqiyrzrcvkxszn Ghqpysp Djlucfqfihlkgvf Lublin Poland
Dftbaopqid Asw Ciqvjcjeps Cojsfu 1 Pxrmhd Ekap Pernik Bulgaria
Tatdrpbk Sgs z omes Piotrkow Trybunalski Poland
Mjiupp Molnmyp swe z ocwr Wroclaw Poland
Hyzkdmribkyguj Dxa Ljsvu Uos Ksysiwpe Stuttgart Germany
Msqcatj Cvsncj Pttmtxqmzd Eqws Haskovo Bulgaria
Ajvdjrljp Mvvefia Cwglkq Ohc Dupnitsa Bulgaria
Kzncktr Onmqxargo &loyk Ttubmhnts Saz z oqhr Warsaw 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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