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

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03146247

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Diamant Thaci

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Diamant Thaci, Prof.
Principal Investigator Affiliation Universität zu Lübeck

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Germany

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Moderate to Severe Plaque Psoriasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Lübeck, Germany

Status

Recruiting

Address

Comprehensive Center for Inflammation Medicine, UKSH

Lübeck, , 23538

Site Contact

Diamant Thaci, Prof.

diamant.thaci@uksh.de

+4945150041601

Nearest Location

Site Contact

Diamant Thaci, Prof.

diamant.thaci@uksh.de

+4945150041601

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