Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the anti-pruritic effect of apremilast in patients with known PN.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanja Todberg, MD
• Treatments: Antipruritics; Apremilast; Thalidomide

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.

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 or 5 pharmacokinetic half-lives, whichever is longer

• 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. Patients with previous endogene depression.

• 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 og sterilization.

• Occlusive cap or condom with spermicidal cream is not considered as an effective contraception. 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

• Allergy to apremilast or any of the other ingredients in Otezla®