Delgocitinib Cream for Palmoplantar Pustulosis

Recruiting at 23 trial locations

Overseen By Clinical Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: LEO Pharma

Must not be taking: Beta blockers, Calcium channel blockers

Disqualifiers: Drug-induced PPP, Active infection, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 16 weeks

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called delgocitinib to determine its effectiveness for people with palmoplantar pustulosis (PPP), a condition causing painful, visible pustules on the palms and soles. Participants will apply either the cream or a placebo (an inactive cream) twice daily for 16 weeks. The trial aims to assess the effectiveness of delgocitinib in reducing PPP symptoms. It is suitable for adults who have had PPP for over six months and have not responded well to usual treatments like topical corticosteroids. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of a potentially effective new therapy.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting, such as systemic treatments like immunosuppressive drugs, retinoids, and corticosteroids, at least 4 weeks prior. Topical treatments on the palms or soles must be stopped 2 weeks before, and other skin treatments 1 week before. Check with the trial team for specific guidance on your medications.

Is there any evidence suggesting that delgocitinib cream is likely to be safe for humans?

Research has shown that delgocitinib cream has been tested in earlier studies to assess its safety for treating skin conditions. Most patients tolerated the cream well. Some experienced mild skin reactions, such as redness or itching, but serious side effects were rare. The current study involves more participants, indicating that earlier trials found the treatment to be relatively safe. Delgocitinib cream is now being tested specifically for palmoplantar pustulosis, a type of skin condition, with a focus on its effectiveness for this particular issue. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Delgocitinib cream is unique because it targets the JAK-STAT pathway, which plays a crucial role in the inflammatory process of palmoplantar pustulosis (PPP). Unlike standard treatments like topical corticosteroids or phototherapy, which focus on reducing inflammation broadly, delgocitinib specifically interferes with the signaling that leads to inflammation, potentially offering a more targeted and effective approach. Researchers are excited about this treatment because it might provide relief with fewer side effects compared to traditional options, making it a promising alternative for those suffering from PPP.

What evidence suggests that delgocitinib cream might be an effective treatment for palmoplantar pustulosis?

This trial will evaluate the effectiveness of delgocitinib cream for treating palmoplantar pustulosis (PPP), a skin condition that causes painful blisters on the hands and feet. Participants in one arm of the trial will receive delgocitinib cream, which earlier studies have shown can reduce symptoms, aiming for at least a 75% improvement by the 16th week. The cream blocks certain proteins in the immune system that cause inflammation. Early results suggest it could significantly reduce the number and severity of these blisters. While more information is needed, these findings offer hope for those with PPP seeking better treatment options. ^{1 2 4 6 7}

Who Is on the Research Team?

Medical Expert

Principal Investigator

LEO Pharma

Are You a Good Fit for This Trial?

Adults with mild to severe palmoplantar pustulosis, a type of psoriasis affecting the palms and soles, can join this trial. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded for various medical reasons.

Inclusion Criteria

A woman of childbearing potential must use an acceptable form of birth control throughout the trial up until the last administration of investigational medicinal product (IMP)

Confirmed PPP by central evaluation of photographs taken at screening

Participant able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator

Exclusion Criteria

My psoriasis covers more than 5% of my body.

I haven't used any antibiotics in the last 2 weeks.

I haven't used any janus kinase inhibitors in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive twice daily applications of delgocitinib cream 20 mg/g or cream vehicle for 16 weeks

16 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delgocitinib Cream

Trial Overview The trial is testing Delgocitinib cream (20 mg/g) against a placebo cream when applied twice daily. The goal is to see if Delgocitinib is more effective in treating symptoms of PPP over a 16-week period compared to the placebo.

How Is the Trial Designed?

Group I: Delgocitinib 20 mg/g Experimental Treatment 1 Intervention

Participants with mild to severe PPP will receive 20 mg/g of delgocitinib cream twice a day for 16 weeks.

Group II: Cream Vehicle Placebo Group 1 Intervention

Participants with mild to severe PPP will receive matching vehicle cream twice a day for 16 weeks.

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials

275

Recruited

189,000+

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07013201

NCT07013201 | A 16-week Trial to Investigate the Efficacy ... A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/​g in Adult Participants With Mild to Severe Palmoplantar Pustulosis.

2. rarediseaseadvisor.com rarediseaseadvisor.com/news/phase-2-trial-recruiting-delgocitinib-palmoplantar-pustulosis/

Phase 2 Trial Recruiting to Test Delgocitinib in ... The trial's primary endpoint is the number of participants achieving at least 75% improvement in PPPASI-75 by week 16. Secondary endpoints ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-of-delgocitinib-cream-for-adults-with-mild-to-severe-palmoplantar-pustulosis-a-16-week-treatment-trial/

Study of Delgocitinib Cream for Adults with Mild to Severe ... The purpose of this research is to evaluate how well delgocitinib cream works when applied twice daily for treating mild to severe palmoplantar pustulosis. The ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07013201?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Pustulosis))&rank=8

A 16-week Trial to Investigate the Efficacy and Safety of ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. patlynk.com patlynk.com/trial/NCT07013201

Delgocitinib Cream for Palmoplantar Pustulosis in Adults This study aims to test how well a cream called delgocitinib works for treating adults with a skin condition known as palmoplantar pustulosis (PPP), ...

6. biospace.com biospace.com/press-releases/leo-pharma-initiates-phase-2a-delta-next-trial-of-delgocitinib-cream-in-adults-with-mild-to-severe-palmoplantar-pustulosis-ppp

LEO Pharma Initiates Phase 2a DELTA NEXT Trial of ... The trial aims to evaluate the efficacy and safety of delgocitinib cream compared to cream vehicle in the treatment of adults with mild to severe Palmoplantar ...

7. go.drugbank.com go.drugbank.com/indications/DBCOND0121301/clinical_trials/DB16133?phase=2&status=recruiting

Palmoplantar Pustulosis (PPP) Recruiting Phase 2 Trials ... A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis ...