Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis

NCT03576287 | Unknown Phase 1 DMC

• 1 other identifier: 2016-003018-29
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prurigo Nodularis

Keywords

apremilast

Outcome Measures

Primary Outcomes (1)

• 1. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast

  1\. Reduction in mean absolute VAS-pruritus score after 12 weeks treatment with apremilast compared to mean VAS-pruritus score before treatment with apremilast

  12 weeks

Study Arms (1)

apremilast

EXPERIMENTAL

apremilast standard doses

Drug: Apremilast Oral Product

Interventions

Apremilast Oral Product DRUG

Apremilast

apremilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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®

Sponsors & Collaborators

• Tanja Todberg, MD: lead

Study Sites (1)

Department of Dermato-Allergology

Hellerup, 2900, Denmark

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, principal investigator

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: July 3, 2018
• Study Start: July 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)