A multicenter, open label, single-arm pilot study to evaluate the efficacy and safety of guselkumab in patients with moderate to severe palmoplantar pustulosis (PPP)

Overview
Related items

Demonstration of improvement in moderate to se-vere chronic PPP after guselkumab administration Evaluation of efficacy and safety of guselkumab application in patients with moderate to severe PPP Determination of improvement of quality of life due to guselkumab administration in patients with moderate to severe PPP Demonstration of improvement in moderate to severe chronic PPP after guselkumab administration

This Trial contains a sub-study with the following related objectives Exploration of the effect of guselkumab on serum, plasma, skin immunological markers, and immuno-logical parameters of the peripheral blood and to identify genetic risk factors

SEEK ID: https://fdm.digital-medicine.org/projects/6

Public web page: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004451-20/DE

Organisms: No Organisms specified

NFDI4Health PIs: No PIs for this Trial Project

Trial Project start date: 17th Jul 2019

Trial Project end date: 20th Jul 2021

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : A multicenter, open label, single-arm pilot study to evaluate the efficacy and safety of guselkumab in patients with moderate to severe palmoplantar pustulosis (PPP)
Language of the title/name : English

Acronym(s) of the Project

Acronym : GAP
Language of the acronym : English

Description(s) of the Project

Description : Demonstration of improvement in moderate to se-vere chronic PPP after guselkumab administration Evaluation of efficacy and safety of guselkumab application in patients with moderate to severe PPP Determination of improvement of quality of life due to guselkumab administration in patients with moderate to severe PPP Demonstration of improvement in moderate to severe chronic PPP after guselkumab administration This Trial contains a sub-study with the following related objectives Exploration of the effect of guselkumab on serum, plasma, skin immunological markers, and immuno-logical parameters of the peripheral blood and to identify genetic risk factors
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Palmoplantar pustulosis

Keyword(*) : guselkumab

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Rheinische Friedrich-Wilhelms-University Bonn represented by the Faculty of Medicine of the University of Bonn represented by the Dean of the Faculty of Medicine, Dermatology Department
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Dagmar
Family name(s)(*) : Wilsmann-Theis
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Clinical Study Core Unit, Study Center Bonn (SCB)
Address : Venusberg Campus 1 53127 Bonn
Web page : https://www.ukbonn.de/studienzentrum-bonn/
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : Other
Identifier(*) : Not specified

Includes chronic diseases? : true

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Single group
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : moderate to severe palmoplantar pustulosis (PPP)
Terminology/classification(*) : Not specified
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : []
On which diseases or conditions were the data collected? : []
Collects mortality data? : No
Administrative information about the Project
Status of the ethics committee approval : Not specified
Overall Project status : Not specified
Participants enrolled by invitation? : Not specified
Start date : 17 July 2019
End date : 20 July 2021
Mono- or multicentric? : Multicentric
Number of centers : 8
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : 1. Male or female, aged 18 years or more at screening visit 2. given written consent to participate in the study 3. has moderate to severe PPP defined as a ppPPPASI ≥ 12 at baseline (week 0) with or without concomitant plaque-type psoriasis 4. a candidate for systemic treatment defined as having PPP inadequately controlled by topical treatment and/or phototherapy and/or previous sys-temic therapy 5. has chronic disease of PPP of 6 months calculated from date at which first symptoms were reported by subject to date of screening visit 6. Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug 7. Agree not to receive a BCG vaccination during the study, or within 12 months after the last administration of study drug 8. Subjects with the ability to follow study instructions and likely to attend and complete all required visits Reproduction-related inclusion criteria Contraceptive (birth control) use by men or women should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with local regulations regarding the use of contraceptive methods for subjects in clinical studies. 9. Before first administration of study drug, a woman must be a. Not of childbearing potential b. Of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method method while receiving study treatment and until 12 weeks after last dose - the end of relevant systemic exposure. Examples of highly effective methods of contraception are located in section 9.4. 10. A woman of childbearing potential must have a negative urine preg-nancy test at screening and agree to urine pregnancy testing before re-ceiving injections and at safety follow-up. 11. A woman must agree not to donate eggs (ova, oocytes) for the pur-poses of assisted reproduction during the study and for a period of 12 weeks after receiving the last administration of guselkumab. 12. A male subject must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. 13. A male subject must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 12 weeks after receiving the last dose of study treatment. TB-related inclusion criteria: 14. It is the responsibility of the investigator to verify the adequacy of previous anti-TB treatment and provide appropriate documentation. a. Have no history of latent or active TB before screening b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before the first administration of study drug. d. Within 2 months before the first administration of study drug, have a negative QuantiFERON®-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated before the first administration of study drug. e. NOTE: The QuantiFERON-TB Gold test is not required at screening for subjects with a history of latent TB and ongoing treatment for latent TB or documentation of having completed ad-equate treatment as described above; subjects with documenta-tion of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB f. Have a chest radiograph (posterior-anterior and lateral views, or per country regulations where applicable), taken within 3 months before the first administration of study drug and read by a quali-fied radiologist, with no evidence of current, active TB or old, inactive TB 15. An exception is made for subjects who have a history of latent TB and a) are currently receiving treatment for latent TB, which must be started at least four weeks until baselinevisit b) will initiate treatment for latent TB conform to the Paul-Ehrlich- In-stitute guidelines before the first administration of study drug, c) or have documentation of having completed appropriate treatment for latent TB within 5 years before the first administration of study drug.
Exclusion criteria : General Exclusion Criteria: 1. Subject without legal capacity or is unable to understand the nature, scope, significance and consequences of this clinical trial 2. Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 4 weeks or 5 pharmacokinetic/pharmacodynamics half-lives (which-ever is longer)prior to participation in present clinical trial 3. Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial 4. Known or persistent abuse of medication, drugs or alcohol Indication specific exclusion criteria: 5. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure or to any components of guselkumab 6. Evidence of skin conditions (eg eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. 7. Ultraviolet B (UVB) therapy, topical steroids, topical calcineurin inhibitors, topical Vitamin A or D analog preparations, or anthralin within 14 days of baseline. Exceptions: low potency corticosteroids will be allowed as therapy for the face, groin, axillae in accordance with the manufacturers suggested usage dose. 8. Psoralen plus ultraviolet A radiation (PUVA), ciclosporin, acitretin, ale-facept (AmeviveTM), anakinra (KineretTM), systemic corticosteroids, methotrexate, fumaric acids, apremilast or any other systemic anti-psoriasis therapy within 28 days of baseline 9. antipsoriatic biologic therapy with TNF-α blockers or IL-17 blockers within 3 months and/or ustekinumab within 4 months 10. Prior treatment with guselkumab or other IL23-blockers 11. Receipt of ANY live (attenuated) vaccine within 3 months prior to baseline (week 0), and BCG vaccination within 12 months of screening. 12. Significant concurrent medical conditions at the time of screening, includ-ing: a. Risk factors for renal toxicity (renal inflammation) b. Severe hepatic dysfunction c. Unstable angina pectoris d. Uncompensated congestive heart failure e. Severe pulmonary disease requiring hospitalization or supple-mental oxygen therapy f. Immunodeficiency disorders: primary or secondary g.Previous test positive for Human immunodeficiency virus (HIV, test result may not be older than 8 weeks at screening date) h. Previous tests positive for hepatitis B virus (HBV) infection or tests seropositive for antibodies to hepatitis C virus (HCV), unless the patient has 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and has a third negative HCV RNA test result at baseline (test results may not be older than 8 weeks at screening date). i. history of active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening. Refer to inclusion criterion 15 and 16 for information regarding eligibility with a history of latent TB j. Uncontrolled Insulin-dependent diabetes mellitus k. Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study drug administration) l. Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly m. Open cutaneous ulcers 13. pustular psoriasis lesions on the part of body other than hands or feet 14. when having a concomitant psoriasis with a PASI ≥12 or BSA ≥10% at screening and/or at baseline
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Analysis of skin lesions at week 24 compared to baseline in moderate to severe chronic PPP under guselkumab therapy, as assessed by palmoplantar Pustulosis Psoriasis Severity Index (ppPASI) score
Type of the outcome measure : Primary
Time point(s) of assessment : week 24 compared to baseline (week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Analysis of skin lesions at all assessment times compared to baseline in moderate to severe chronic PPP under guselkumab therapy, as assessed by ppPASI score
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Evaluation of safety of guselkumab in patients with moderate to severe PPP, as assessed by AEs
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Evaluation of possible alterations in quality of life assessement measures during guselkumab-treatment: Dermatology Life Quality Index (DLQI) palmoplantar Quality of Life (ppQoL) and work productivity and activity impairment questionnaire-psoriasis (WPAI-Pso) at all assessment times com-pared to baseline
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Evaluation of time course of Hand and Feet Physician Global Assessment (H&F PGA) at all assessment times
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Absolute and percent change in PPSI score as compared to baseline during the 24 weeks treat-ment period
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Pustules count 50 response or Pustules count 75 response defined as a minimum of 50% or a minimum of 75% decrease in Pustules count re-spectively as compared to baseline, during the 24 weeks treatment period
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Evaluation of differences in the mean change of Numereous Analogue Scale (NRS) discomfort / pain, NRS pruritus / itch at all assessment times as compared to day 0 (baseline)
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Name of the outcome measure(*) : Not specified
Description of the outcome measure : Evaluation of changes in Psoriasis Area Severi-ty Index (PASI) and Physician Global Assessment (PGA) if plaque psoriasis is present comparing baseline to all assessment times
Type of the outcome measure : Secondary
Time point(s) of assessment : all assessment timepoints (week 4, 12 , 24 and 32 depending on the endpoint) compared to week 0 (baseline) For AEs and SAEs assessment aditionally on week 20 (no comparison to week 0)
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Not specified
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Not specified
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

A multicenter, open label, single-arm pilot study to evaluate the efficacy and safety of guselkumab in patients with moderate to severe palmoplantar pustulosis (PPP)

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