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

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 Overview

• Status: Withdrawn
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Lübeck, Germany, 23538
    • Comprehensive Center for Inflammation Medicine, UKSH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Subjects must be at least 18 years of age at time of enrollment
3. 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)
4. Subjects must have a score in the numerical rating scale (NRS, see 12.4) >5 at baseline

5. 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:

1. Patients with previous treatment with Apremilast
2. Patients incapable of giving full informed consent.Patients enrolled in other clinical trials
3. 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)
4. Rifampicin, Phenobarbital, Carbamazepine, Phenytoin, enzalutamid, mitotan or St John's Wort as concomitant medication
5. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
6. Allergy to local anaesthetic or latex
7. Pregnancy/Lactation
8. Patients with known HIV infection and active or uncontrolled hepatitis B or C infection
9. Patients with known disposition for excessive keloid formation or wound healing disorders
10. Patients with other forms than chronic plaque type psoriasis especially drug-induced psoriasis
11. Patients who cannot tolerate the complete dose used in this study due to medical conditions e.g. due to kidney insufficiency
12. Patients with depressive symptom in PHQ-D in visit 1
13. Concomitant medication that can cause psychiatric symptoms
14. Psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: One arm; all patients receive same dose and dosing regimen with Apremilast	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunoreactive nerve fibers	Proportion of patients reaching 50% reduction of PGP 9-5- immunoreactive nerve fibers at visit 6 (week 16) compared to visit 1 (week 0) measured with immunohistochemical methods	until week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI improvement	Proportion of patients achieving at least 50 % of improvement of PASI at visit 6 (week 16) compared to visit 1 (week 0)	until week 16

Collaborators and Investigators

• Sponsor: Diamant Thaci
• Investigators: Principal Investigator: Diamant Thaci, Prof., Universität zu Lübeck

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2017
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: C16.Pso-002; 2016-002432-32 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No