Patients with symptomatic Prurigo nodularis with active skin manifestations MedDRA version: 20.0 Level: LLT Classification code 10037084 Term: Prurigo nodularis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: PT Classification code 10037083 Term: Prurigo System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Ruxolitinib
Pharmaceutical Form: Cream
INN or Proposed INN: RUXOLITINIB
Other descriptive name: RUXOLITINIB
Concentration unit: % percent
Concentration number: 1,5-
Pharmaceutical form o
Sponsors
Rheinische Friedrich-Wilhelms-Universität Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will only be included in the study if they meet all of the following criteria: 1) Age =18 years 2) Written informed consent of the subject for voluntary participation in the study. 3) Subjects with the ability to follow study instructions and likely to attend and complete all required visits 4) Patients with clinically confirmed symptomatic Prurigo nodularis 5) Lesions involve body surface area of at least 4.5% up to a maximum of 36% (according to the “rule of nine”(1), APPENDIX Figure 1) 6) Numeric Rating Scalevalue for average itch (Itch NRS) of at least 4.0 (4.0-10.0) during the past 24 hours before screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if any of the following criteria applies: 1) Patients without legal capacity or unable to understand the nature, scope, significance and consequences of this clinical trial 2) Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical trial or may prevent sufficient compliance 3) Known or persistent abuse of medication, drugs or alcohol within 365 days prior to screening 4) Change in systemic or topical treatment of prurigo nodularis within the last 14 days before screening (care products and topical immunomodulators excluded, topical immunomodulators have to be stopped 7 days before screening ) 5) Known hypersensitivity to any component of the formulation of the IMP 6) Chronic or acute infectious disease (including HIV, Hepatitis B or C infection), disease predisposing for infectious disease or recurring infectious diseases in the history, except for patients with stable chronic Hepatitis B or C as long as their liver values are within normal limits (ULN = 3) 7) Patients with a current diagnosis of a solid malignant tumor or a history of a solid malignant tumor within the last 5 years (patients with heaemato-oncological malignancies can be included, patients with basal-cell-carcinoma of the skin can be included, patients with a history of a solid malignant tumor in remission for > 5 years can be included). 8) Patients treated within the last 4 weeks before baseline with oral ruxolitinib or any other JAK-specific inhibitor 9) Women who are pregnant or breast-feeding 10) Patients with reproductive potential who do not accept to use contraception or to adhere to sexual abstinence during the trial and 30 days thereafter 11) Prior treatment with an IMP in a different clinical trial either less than 30 days or if not yet reached a minimum of a 5-fold terminal elimination halflife of the respective IMP or one of it's metabolites. The longer of the respective periods shall be applied. 12) Neutrophil count less than lower limit of normal, hemoglobin concentration < 10 g/dL, and platelet count < 100 G/l 13) Presence of cytopenia (defined as leucocyte count < 3 G/l) - depending on the physician's assessment 14) Lymphocyte count < 0.8 G/l - depending on the physician's assessment
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Change in Prurigo Activity Score (PAS) from baseline (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients ? Change of DQLI from baseline (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients ? Change of IGA-CNPG S/A (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients ? Change of Itch NRS from baseline (V1) to V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients ? Change of PAS from baseline (V1) to V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients ? Change of DPS from baseline (V1) to V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients ? Change of IGA-CNPG S/A from screening (V0) to baseline (V1), V2, V3, V4, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients ? Change of DLQI from baseline (V1) to V3, V5/OLE-V1, OLE-V2, OLE-V3, OLE-V4 in placebo and ruxolitinib-treated patients ? Change in gene expression profile in serum (V1 vs V5) ? Change in gene expression profile in lesion (V0 vs V5) ? Change in lesional histological acanthosis score (V0 vs V5);Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of secondardy end point see E.5.2 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of ruxolitinib cream on itching skin lesions in Prurigo nodularis ;Secondary Objective: ? Reduction of Itching symptoms ? Reduction of inflammatory parameters in skin lesions ? Improvement in quality of life ;Primary end point(s): Change in numeric rating scale (NRS) for itch from baseline (V1) to EOS (V5) in placebo versus ruxolitinib-treated patients;Timepoint(s) of evaluation of this end point: EOS (V5); Timepoint of evaluation of secondardy end point see E.5.1 | — |
Countries
Germany
Contacts
Public ContactVerena Proß
Studienzentrale Studienzentrum Bonn (SZB)
Outcome results
None listed