Prurigo nodularis
Conditions
Interventions
Trade Name: Otezla
Product Name: apremilast
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: apremilast
CAS Number: 608141-4
Sponsors
Herlev and Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • > 18 years of age • PN verified diagnosis by characteristic clinical features • Moderate to severe PN • Failure of local steroid and light treatment to control disease and symptoms. • Be able to speak and understand Danish. • Patients must have given their informed consent to the protocol and to the clinical procedures. 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who have received any local anti-inflammatory treatment 2 weeks prior to day 0 • Patients who have received any systemic anti-inflammatory treatment 4 weeks prior to day 0 • Patients who have received any other study medication 4 weeks prior to day 0 • Patients with other clinically significant disorders • Patients with active TB/serious infections • Any psychiatric condition which in the Investigators opinion would preclude the patient from adhering to the protocol or completing the study per protocol • Pregnancy • Nursing • Women of child-bearing potential must use effective contraception which includes IUD, oral, injected or implanted hormonal device, hormone patch, vaginal hormonal ring, sterilization, occlusive cap or condom with spermicidal cream. Post-menopausal women (> 12 months of amenorrhea) are allowed not to use contraception. • Patients who have received any live vaccines 6 weeks prior to day 0 or who are planning to receive a live vaccine during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast;Timepoint(s) of evaluation of this end point: 12/2019; Main Objective: This study will evaluate the anti-pruritic effect of apremilast in patients with known PN. 1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast ; Secondary Objective: 1. Reduction in PGA score after 12 weeks treatment with apremilast compared to PGA score before treatment with apremilast. A decrease in PGA score of at least 2 points from baseline level will be considered as a successful reduction 2. Reduction in DLQI score after 12 weeks treatment with apremilast compared DLQI score before treatment with apremilast 3. Reduction in PtGA score after 12 weeks treatment with apremilast compared to PtGA score before treatment with apremilast 4. Improvement in sleep quality after 12 weeks treatment with apremilast compared to sleep quality before treatment with apremilast using a self-administered questionnaire. 5. Reduction in level of inflammatory cytokines in blood after 12 weeks treatment with apremilast compared to inflammatory cytokine level before treatment with apremilast 6. Increase in level of IL-10 (anti-inflammatory cytokine) in blood after 12 weeks treatment with apremilast compared to IL-10 level before treatment with apremilast | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please see section E2;Timepoint(s) of evaluation of this end point: 12/2019 | — |
Countries
Denmark
Contacts
Public ContactDept of Dermatology and Allergy
Herlev and Gentofte Hospital
Outcome results
None listed