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Study Comparing BP11 and Omalizumab for Patients with Chronic Spontaneous Urticaria Resistant to H1 Antihistamines

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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, which is a type of chronic hives that occurs without a known cause and does not respond well to standard allergy medications called H1 antihistamines. The study aims to compare the effectiveness and safety of a new treatment called BP11 with an existing medication known as Xolair (also referred to by its scientific name, omalizumab). Both treatments are given as injections under the skin using pre-filled syringes.

The purpose of the study is to determine if BP11 works as well as Xolair in treating patients with this type of chronic hives. Participants in the study will receive either BP11, Xolair, or a placebo, which is an inactive substance. The study will last for several months, during which participants will receive regular injections and attend scheduled visits to monitor their condition and any changes in their symptoms. The study will also assess the safety of the treatments by monitoring any side effects or reactions that may occur.

Throughout the study, participants will be asked to keep a diary of their symptoms and any changes they experience. This information will help researchers understand how well the treatments are working and if there are any differences between them. The study will also involve regular check-ups, including physical exams and laboratory tests, to ensure the safety and well-being of the participants. The ultimate goal is to find an effective treatment option for those who suffer from Chronic Spontaneous Urticaria and have not found relief with current medications.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of chronic spontaneous urticaria (CSU) for at least six months, and inadequate response to H1 antihistamine treatment.
Participants must provide e-diary entries for the last seven consecutive days before randomization and agree to continue this practice twice daily.
Step 2
Randomization and baseline measurements
Participants are randomly assigned to receive either BP11 or Xolair (omalizumab) in a double-blind manner, meaning neither the participant nor the study team knows which treatment is being administered.
Baseline measurements are taken, including physical examinations, vital signs, and laboratory tests.
Step 3
Treatment period 1
Participants receive subcutaneous injections of the assigned treatment every four weeks. The dosage is 150 mg per injection.
Regular assessments are conducted at Weeks 4, 8, and 12 to monitor changes in itch severity and urticaria activity scores, as well as any adverse reactions.
Step 4
Mid-study evaluation
At Week 12, a comprehensive evaluation is performed to assess the primary endpoint, which is the change in weekly itch severity score from baseline.
Secondary endpoints, such as changes in urticaria activity and quality of life scores, are also evaluated.
Step 5
Treatment period 2
Participants continue receiving their assigned treatment every four weeks, with additional assessments at Weeks 16, 20, and 24.
Monitoring includes physical examinations, vital signs, laboratory tests, and evaluation of any adverse events.
Step 6
Final assessment
At the end of the study period, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.
Participants' responses to treatment, including any changes in symptoms and quality of life, are documented.

Who can join the trial?

7 criteria

Male or female patients aged 18 to 75 years who are willing and able to provide informed consent.
A diagnosis of **Chronic Spontaneous Urticaria (CSU)** for at least 6 months before joining the study. CSU is a condition where hives appear on the skin without a known cause.
A diagnosis of CSU that does not respond well to **H1 antihistamine (H1AH)** treatment. H1 antihistamines are medications used to relieve allergy symptoms.
Able to provide entries in a patient **e-diary** (an electronic diary) without missing data for the last 7 consecutive days before joining the study.
Willing to complete the e-diary twice daily, in the morning and evening, and able to provide entries for at least 4 consecutive days out of 7 days before joining the study.
Females who can have children and males with a female partner who can have children must be willing to use reliable birth control methods throughout the study and for 6 months after the last study treatment dose.
If the patient is a female who can have children, they should have a negative pregnancy test result at the Screening and Baseline visits.

Who cannot join the trial?

1 criterion

No specific exclusion criteria were provided for this clinical trial.

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Verified sites

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

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Verified
Cracow, Poland
Synexus Polska Sp. z o.o.
Verified
Poznan, Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Responsive
Rzeszow, Poland

Trial locations

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Investigated drugs

BP11
is a medication being tested in this study to see if it works as well as another treatment for chronic spontaneous urticaria, a condition that causes hives and itching. The study aims to find out if BP11 can help patients who do not get enough relief from standard antihistamine treatments.
Xolair
is an existing medication used to treat chronic spontaneous urticaria in patients who do not respond well to antihistamines. In this study, Xolair is being used as a comparison to evaluate the effectiveness of BP11.

Omalizumab

What is already known about the treatment

Xolair
Xolair is administered as an injection under the skin, typically in a healthcare setting. It is currently well-established in medical literature and is used for treating chronic spontaneous urticaria, especially in patients who do not respond adequately to H1 antihistamines. The medication works by targeting and blocking a protein called IgE, which plays a key role in allergic reactions, thereby reducing symptoms. Xolair is classified as a monoclonal antibody, specifically designed to interfere with the immune system's response to allergens.
BP11
BP11 is administered as an injection under the skin, similar to Xolair, and is currently being studied in clinical trials to establish its efficacy and safety. It is intended for use in patients with chronic spontaneous urticaria who have not responded well to H1 antihistamines. BP11 aims to demonstrate therapeutic equivalence to Xolair by also targeting the IgE protein, which is involved in allergic reactions, to alleviate symptoms. It is classified as a monoclonal antibody, focusing on modulating the immune response.

Investigated diseases

Chronic Urticaria – Chronic urticaria is a condition characterized by the presence of hives or wheals on the skin that persist for six weeks or longer. These hives are often itchy and can vary in size and shape, appearing anywhere on the body. The condition can be spontaneous, with no identifiable trigger, or induced by specific factors such as pressure, temperature changes, or stress. The hives may come and go, with periods of flare-ups and remissions. Chronic urticaria can significantly impact a person's quality of life due to persistent itching and discomfort. The exact cause is often unknown, but it may involve an immune system response.