Study on the Effects of Sonelokimab for Patients with Moderate-to-Severe Palmoplantar Pustulosis

1 1

What is this study about?

This clinical trial is focused on studying a skin condition called Palmoplantar Pustulosis, which is characterized by the appearance of pustules on the palms of the hands and the soles of the feet. The study will explore the effects of a treatment called Sonelokimab, which is administered as an injection under the skin. The purpose of the study is to evaluate how effective Sonelokimab is in improving the condition of the skin in patients with moderate-to-severe Palmoplantar Pustulosis.

Participants in the study will receive Sonelokimab injections over a period of 16 weeks. During this time, the study will monitor changes in the severity of the skin condition using a specific measure known as the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI). This index helps to assess the extent and severity of the skin condition. The study aims to see if there is an improvement in the PPPASI score from the beginning of the study to the end of the 16-week period.

The study is open-label, meaning that both the participants and the researchers will know that Sonelokimab is being administered. This trial is being conducted at multiple centers, allowing for a diverse group of participants. The results of this study will help to determine the potential benefits of Sonelokimab for individuals suffering from moderate-to-severe Palmoplantar Pustulosis.

1 initial treatment phase

The study involves the use of sonelokimab, which is administered as a subcutaneous injection. This means the medication is injected under the skin.

The primary goal is to observe the improvement in the Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) over a period of 16 weeks.

2 treatment administration

Participants receive sonelokimab injections at specified intervals. The exact dosage and frequency are determined by the study protocol and are designed to assess the medication’s effectiveness and safety.

3 monitoring and assessment

Throughout the study, participants are monitored for changes in their condition. This includes regular assessments of the PPPASI score to evaluate the treatment’s impact.

Participants are required to complete electronic diary entries to provide additional data on their condition and any side effects experienced.

4 final evaluation

At the end of the 16-week period, a final assessment is conducted to determine the percent change in the PPPASI score from the baseline.

This evaluation helps to understand the overall effectiveness of sonelokimab in treating moderate-to-severe palmoplantar pustulosis.

Who Can Join the Study?

Participants must be at least 18 years old at the time of signing the informed consent.
Participants must have a history of Palmoplantar Pustulosis (PPP) for at least 6 months. This is a skin condition affecting the palms of the hands and soles of the feet.
Participants should be eligible for treatment with systemic therapy, which means treatments that affect the entire body, because their PPP is not well controlled by creams, light therapy, or previous systemic treatments.
Participants must have moderate-to-severe PPP, which is measured by a score called PPPASI of 12 or higher. This score assesses the area and severity of the condition.
Female participants must not be pregnant or breastfeeding. They must either be unable to have children or agree to use highly effective birth control methods during the study and for at least 8 weeks after the last dose of the study treatment. They must also have a negative pregnancy test before starting the study treatment.
Male participants must agree to use a condom when sexually active with a partner who can have children during the study and for at least 8 weeks after the last dose of the study treatment, unless they have had surgery to prevent having children.
Participants must be able to give signed informed consent, which means they understand and agree to the study’s requirements and restrictions.
Participants must complete at least 4 out of 7 days of electronic diary entries in at least 1 of the 2 weeks before starting the study.

Who Cannot Join the Study?

Having any other skin condition that might interfere with the study results.
Having a history of severe allergic reactions to medications.
Being pregnant or breastfeeding.
Having a serious infection or illness that requires treatment.
Using certain medications that might affect the study results.
Having a history of drug or alcohol abuse.
Participating in another clinical trial recently.
Having a medical condition that the study doctor thinks might make it unsafe to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Uokuggvkylpcmlsvyrogb Eydkh Axd	Essen	Germany
Tfcigtrjvvj uxk Soergoqyarq Bhlztroz Gqse	Bad Bentheim	Germany
Uwuavnsokygmhthrviwtm Mlvxrvrj Anc	Munster	Germany
Ggwcdu Uyetmfkpdo Fqkslvfix	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	16.09.2024

Trial locations

Investigated drugs:

Sonelokimab

Sonelokimab is a medication being studied for its effects on patients with moderate-to-severe pustulosis palmoplantaris, a type of psoriasis that affects the palms of the hands and soles of the feet. The trial aims to see how well sonelokimab can improve the condition by measuring changes in the severity and area of the skin affected by the disease over a 16-week period.

Investigated diseases:

Palmoplantar pustulosis

Palmoplantar Pustulosis – This is a chronic skin condition characterized by the appearance of pustules on the palms of the hands and the soles of the feet. The pustules are often filled with pus and can be painful, leading to discomfort in affected areas. Over time, the skin may become red, scaly, and thickened, which can cause further irritation. The condition tends to have periods of flare-ups and remissions, where symptoms may improve or worsen. It is not considered a rare disease and can significantly impact daily activities due to the discomfort it causes.

Trial ID:

2024-513305-32-00

Protocol code:

M1095-PPP-201

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Effects of Sonelokimab for Patients with Moderate-to-Severe Palmoplantar Pustulosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?