Trial | NCT03146247  Report issue

Official Title

Analysis of the Pathogenesis of Itch in Response to Apremilast Therapy in Psoriasis Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    apremilast ...

  • Study Participants

    0
This study aims to identify and describe the presence of itch active molecules in psoriasis and response to treatment with apremilast. This data will be complemented by immunohistochemical data determining nerve ending density and neuropeptide concentrations before and during treatment and correlated with patient reported outcome. It is important to underscore that itch may interfere with various aspects of patient functioning, emotions and social status and should therefore be adequately addressed while treating patients with psoriasis
Study Started
Oct 23
2017
Primary Completion
Mar 01
2019
Study Completion
Mar 01
2019
Last Update
Apr 18
2019

Drug Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet

All patients are scheduled to receive Apremilast with a titration phase of one week, followed by 23 weeks of regular treatment.

One arm Other

all patients receive same dose and dosing regimen with Apremilast

Criteria 

Inclusion Criteria:

Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.
Subjects must be at least 18 years of age at time of enrollment
Patients with chronic moderate to severe plaque type psoriasis who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA)
Subjects must have a score in the numerical rating scale (NRS, see 12.4) >5 at baseline

Women of childbearing potential* and males with female partners of child bearing potential must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Women of childbearing potential are defined as:

Having experienced menarche and
not Postmenopausal (12 months with no menses without an alternative medical cause) and
not permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)

Exclusion Criteria:

Patients with previous treatment with Apremilast
Patients incapable of giving full informed consent.Patients enrolled in other clinical trials
Allergies against Apremilast or any of the inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, iron oxide yellow (20 and 30 mg only) and iron oxide black (30 mg only)
Rifampicin, Phenobarbital, Carbamazepine, Phenytoin, enzalutamid, mitotan or St John's Wort as concomitant medication
Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
Allergy to local anaesthetic or latex
Pregnancy/Lactation
Patients with known HIV infection and active or uncontrolled hepatitis B or C infection
Patients with known disposition for excessive keloid formation or wound healing disorders
Patients with other forms than chronic plaque type psoriasis especially drug-induced psoriasis
Patients who cannot tolerate the complete dose used in this study due to medical conditions e.g. due to kidney insufficiency
Patients with depressive symptom in PHQ-D in visit 1
Concomitant medication that can cause psychiatric symptoms
Psychiatric disorders
No Results Posted