Apremilast as anti-pruritic treatment in patients with prurigo nodularis

Phase 1

• Conditions: Prurigo nodularis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-003018-29-DK
• Lead Sponsor: Herlev and Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-03
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified