Adult men and women with palmoplantar pustulosis MedDRA version: 21.1 Level: PT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Guselkumab
Product Code: CNTO 1959
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Guselkumab
CAS Number: 1350289-85-8
Current Sponsor code: CNTO 1
Sponsors
Rheinische Friedrich-Wilhelms-Universität Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential subject must satisfy all of the following criteria to be enrolled in the study: 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 a
Exclusion criteria
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-a 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of improvement in moderate to se-vere chronic PPP after guselkumab administration ;Secondary Objective: 1. Evaluation of efficacy and safety of guselkumab application in patients with moderate to severe PPP 2. Determination of improvement of quality of life due to guselkumab administration in patients with moderate to severe PPP 3. Demonstration of improvement in moderate to severe chronic PPP after guselkumab administration ;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: week 24 compared to baseline (week 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 a) 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 1 b) Evaluation of safety of guselkumab in patients with moderate to severe PPP, as assessed by AEs 2 a) 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 3 a) Evaluation of time course of Hand and Feet Physician Global Assessment (H&F PGA) at all assessment times. 3 b) Absolute and percent change in PPSI score as compared to baseline during the 24 weeks treat-ment period. 3 c) 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 3 d) 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) 3 e) 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 ;Timepoint(s) of evaluation of this end point: 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) | — |
Countries
Germany
Contacts
Public ContactDr. rer. nat. Judith Schilling
Studienzentrale Studienzentrum Bonn (SZB)
Outcome results
None listed