Authorised Therapeutic exploratory (Phase II) Mild to severe palmoplantar pustulosis

A 16-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g Compared to a Dummy Cream in Adult Subjects With Mild to Severe Palmoplantar Pustulosis

EU CTIS ID: 2024-518856-21-00

What this study is testing

To evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult subjects with mild to severe PPP.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Signed and dated informed consent has been obtained prior to any protocol-related procedures.
2. Age 18 years or above at the time of informed consent signing.
3. Subject is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
4. Diagnosis of PPP in accordance with the consensus diagnostic criteria established by the European Rare and Severe Psoriasis Expert Network (ERASPEN): primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, with or without plaque psoriasis elsewhere on the body.
5. Confirmed PPP by central evaluation of photographs taken at screening.
6. Mild to severe PPP current condition defined by: • Disease duration of PPP of >6 months before randomisation. • PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline. • Palmoplantar Pustulosis Area and Severity Index (PPPASI) ≥8 at screening and baseline.

You likely can't join if

1. Presence or known history of drug-induced PPP
10. Any disorder which is not stable and could: • Affect the safety of the subject throughout the trial. • Impede the subject’s ability to complete the trial.
11. Any clinically significant abnormal findings occurring during the screening period and/or observed at the baseline visit that may put the subject at risk because of their participation in the trial, or can influence the subjects ability to complete the trial.
12. Positive hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus DNA (subjects who have tested positive for hepatitis B core antibody are eligible if tests for hepatitis B surface antigen and hepatitis B virus DNA are negative), or positive hepatitis C virus antibody serology confirmed by hepatitis C virus RNA at screening.
13. Known or suspected hypersensitivity to any component(s) of the IMP.
14. Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.

See the full eligibility criteria

Who can join

1. Signed and dated informed consent has been obtained prior to any protocol-related procedures.
2. Age 18 years or above at the time of informed consent signing.
3. Subject is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
4. Diagnosis of PPP in accordance with the consensus diagnostic criteria established by the European Rare and Severe Psoriasis Expert Network (ERASPEN): primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, with or without plaque psoriasis elsewhere on the body.
5. Confirmed PPP by central evaluation of photographs taken at screening.
6. Mild to severe PPP current condition defined by: • Disease duration of PPP of >6 months before randomisation. • PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline. • Palmoplantar Pustulosis Area and Severity Index (PPPASI) ≥8 at screening and baseline.
7. Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline.
8. Subjects with prior experiences of inadequate response with topical corticosteroids (TCS) or for whom TCS are inadvisable, as judged by the investigators.
9. A woman of childbearing potential must use an acceptable form of birth control throughout the trial up until the last administration of IMP.

What rules you out

1. Presence or known history of drug-induced PPP
10. Any disorder which is not stable and could: • Affect the safety of the subject throughout the trial. • Impede the subject’s ability to complete the trial.
11. Any clinically significant abnormal findings occurring during the screening period and/or observed at the baseline visit that may put the subject at risk because of their participation in the trial, or can influence the subjects ability to complete the trial.
12. Positive hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus DNA (subjects who have tested positive for hepatitis B core antibody are eligible if tests for hepatitis B surface antigen and hepatitis B virus DNA are negative), or positive hepatitis C virus antibody serology confirmed by hepatitis C virus RNA at screening.
13. Known or suspected hypersensitivity to any component(s) of the IMP.
14. Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.
15. Women who are pregnant or lactating.
16. Systemic treatment within 4 weeks prior to baseline with immunosuppressive, immunomodulating drugs, retinoids tyrosine kinase inhibitors, phosphodiesterase-4 inhibitors, or corticosteroids.
17. Use of tanning beds or phototherapy on the palms or soles within 4 weeks prior to baseline.
18. Use of systemic or topical janus kinase inhibitors within 4 weeks prior to baseline.
19. Cutaneously applied treatment with immunomodulators or TCS on the palms or soles within 2 weeks prior to baseline.
2. Presence of acrodermatitis continua of Hallopeau.
20. Use of systemic antibiotics or cutaneously applied antibiotics on the palms or soles within 2 weeks prior to baseline.
21. Other transdermal or cutaneously applied therapy on the palms or soles (except for the use of subject’s own non-medicated emollients) within 1 week prior to baseline
22. Cutaneously applied treatments in regions other than the palms or soles, which could interfere with clinical trial evaluations or pose a safety concern (excluding treatments for psoriasis patches or other non-exclusionary skin conditions, if needed) within 1 week prior to baseline.
23. Treatment with any marketed biological therapy or investigational biologic agents: • Any cell-depleting agents including, but not limited to, rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. • Other biologics, including but not limited to, secukinumab, ustekinumab, tildrakizumab, ixekizumab, risankizumab, guselkumab, and tumour necrosis factor-alpha inhibitors: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
24. Treatment with any nonmarketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to baseline or 5 half-lives, whichever is longer.
25. Current participation in any other interventional clinical trial.
26. Previously randomised in this clinical trial.
27. Previously randomised in a clinical trial with delgocitinib.
28. Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.
3. Active dermatologic condition that could confound the diagnosis of PPP or interfere with assessment of the IMP, as assessed by the investigator
4. Clinically significant infection on the palms or soles.
5. Concurrent plaque psoriasis covering >5% of body surface area.
6. Clinically significant infection within 4 weeks prior to baseline. Clinically significant infections are defined as: • A systemic infection. • A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, parenteral antiviral, or parenteral antifungal medication.
7. History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus test at screening
8. Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalisation during the trial period
9. Any documented active or suspected malignancy, or history of malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix appropriately treated before the baseline visit.

The study team makes the final eligibility decision.

Where it's taking place

United States
United Kingdom
Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.