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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial 12-week treatment period
You will receive either ritlecitinib tosilate or a placebo (a pill with no active medicine) to take by mouth.
If assigned to the ritlecitinib tosilate group, you will take either 50 mg or 100 mg of the capsule once daily.
This initial phase lasts for 12 weeks.
You may also take loratadine, which is a 10 mg oral medication, as part of your background treatment.
Step 2
12-week extension period
After the first 12 weeks, there is a double-blind extension period that lasts for an additional 12 weeks.
During this time, you will continue to take either the active medicine or the placebo.

Who can join the trial?

5 criteria

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 trial?

4 criteria

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.

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Verified sites

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Centrum Badan Klinicznych Pi-House Sp. z o.o.
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Gdansk, Poland
Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
M2m Med. Sp. z o.o.
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Chorzow, Poland

Trial locations

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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.

Loratadine

What is already known about the treatment

Ritlecitinib tosilate
This medication is an oral capsule currently being studied in clinical trials for its ability to treat chronic spontaneous urticaria, a condition involving persistent skin hives. It belongs to a class of drugs known as JAK inhibitors, which work by blocking specific proteins inside immune cells to stop the overactive signals that cause inflammation. By calming these cellular pathways, the drug helps reduce the redness and itching associated with skin reactions.
Loratadine
This is a common oral medication used to manage symptoms of allergies, such as hives and itching. It is classified as an antihistamine and works by blocking histamine, a natural chemical in the body that triggers allergic reactions. By preventing histamine from attaching to its receptors, the drug helps relieve skin irritation and other allergy-related discomfort.

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.