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Study on the Effects and Safety of Povorcitinib for Adults with Chronic Spontaneous Urticaria

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a condition known as Chronic Spontaneous Urticaria (CSU), which is a type of hives that occurs without a known cause and lasts for more than six weeks. The study is evaluating a medication called Povorcitinib, which is taken in the form of a tablet. Povorcitinib is being tested to see how effective and safe it is for adults who have CSU that does not respond well to standard treatments like second-generation H1 antihistamines.

The purpose of the study is to assess how well Povorcitinib works in reducing the symptoms of CSU. Participants in the study will be randomly assigned to receive either Povorcitinib or a placebo, which looks like the medication but does not contain the active ingredient. The study will be conducted over a period of time, during which participants will take the medication and have regular check-ups to monitor their condition and any changes in their symptoms.

Throughout the study, participants will be asked to keep a daily electronic diary to record their symptoms and any side effects they experience. This information will help researchers understand how Povorcitinib affects CSU and whether it can help control the symptoms of this condition. The study aims to provide valuable insights into the potential benefits of Povorcitinib for people living with Chronic Spontaneous Urticaria.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be required to sign a written informed consent form. This indicates understanding and agreement to participate in the study.
Participants must be between 18 and 65 years old and have a diagnosis of chronic spontaneous urticaria (CSU) for at least 3 months prior to the screening.
Step 2
Screening and baseline assessment
Participants will undergo a screening process to confirm eligibility, including a review of medical history and current health status.
Baseline assessments will be conducted to establish initial health metrics and CSU severity.
Step 3
Randomization and treatment
Participants will be randomly assigned to receive either povorcitinib or a placebo. The study is double-blind, meaning neither the participants nor the researchers will know who receives the actual medication.
The medication is administered orally in tablet form. The dosage and frequency will be determined by the study protocol.
Step 4
Treatment period
Participants will take the assigned medication for a specified period, with regular monitoring to assess the efficacy and safety of the treatment.
Participants are required to complete a daily electronic diary (eDiary) to record symptoms and any side effects experienced.
Step 5
Evaluation of outcomes
The primary outcome is the change from baseline in the Urticaria Activity Score over 7 days (UAS7) at Week 12.
Secondary outcomes include the proportion of participants achieving controlled disease (UAS7 ≤ 6) and those with UAS7 = 0 at Week 12.
Step 6
End of study
The study is estimated to conclude by July 11, 2025. Participants will undergo final assessments to evaluate the overall impact of the treatment.
Participants will be informed of the study results and any potential next steps regarding their treatment.

Who can join the trial?

7 criteria

Must be able to understand and willing to sign a written document agreeing to participate in the study.
Must be between 18 and 65 years old at the time of signing the agreement.
Must have been diagnosed with **Chronic Spontaneous Urticaria (CSU)** for at least 3 months before the screening. **Chronic Spontaneous Urticaria** is a condition where hives or welts appear on the skin without a known cause and last for a long time.
Must have **CSU** that does not improve with second-generation **H1 antihistamines**. **H1 antihistamines** are medicines used to relieve allergy symptoms like itching and hives.
Must be willing and able to follow the study's rules and procedures.
Must be willing and able to fill out a daily electronic diary for the entire study period.
Must agree to use birth control methods as described in the study's guidelines.

Who cannot join the trial?

8 criteria

Participants who have a history of severe allergic reactions to any of the ingredients in the study medication.
Individuals currently taking medications that might interfere with the study treatment.
People with other skin conditions that could affect the study results.
Participants with significant health issues, such as heart, liver, or kidney problems.
Women who are pregnant or breastfeeding.
Individuals who have participated in another clinical trial recently.
People who have a history of drug or alcohol abuse.
Participants who are unable to follow the study procedures or attend study visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Dc-Med Michal Kowalski sp.k.
Swidnica, Poland

Trial locations

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Investigated drugs

Povorcitinib is a medication being studied for its effectiveness in treating chronic spontaneous urticaria (CSU), a condition characterized by persistent hives without an apparent cause. The trial aims to assess how well this medication works in reducing the symptoms of CSU and to ensure its safety for use in adults.

Povorcitinib

What is already known about the treatment

Povorcitinib – Povorcitinib is administered orally in the form of tablets. It is currently being studied in clinical trials, specifically in a Phase 2 study, to assess its effectiveness and safety for treating Chronic Spontaneous Urticaria (CSU). The main therapeutic indication for Povorcitinib is to alleviate symptoms associated with CSU, a condition characterized by persistent hives without an identifiable cause. At the molecular level, Povorcitinib works by inhibiting certain enzymes involved in the inflammatory process, which helps reduce the occurrence of hives. It is classified pharmacologically as a Janus kinase (JAK) inhibitor, targeting pathways that contribute to inflammation and immune response.

Investigated diseases

Chronic Spontaneous Urticaria – This is a skin condition characterized by the sudden appearance of hives, which are red, itchy welts on the skin. These hives can appear anywhere on the body and may vary in size and shape. The condition is termed "spontaneous" because the hives occur without an obvious trigger. It is considered chronic when the hives persist for six weeks or longer. The severity and frequency of the hives can fluctuate over time. The exact cause of chronic spontaneous urticaria is often unknown, but it involves the immune system.