Clinical study on
Prurigo Nodularis
Do you suffer from intensely itching bumps on the arms, legs or trunk?
We are looking for patients to take part in a clinical study for the chronic inflammatory skin condition Prurigo Nodularis.
Potential participants must fulfil certain requirements in order to take part in the study.
Study information
Phase 2
18+ years of age
Oral intake of three tablets daily
Possible symptoms and consequences of Prurigo Nodularis
Symptoms
- multiple symmetrical nodules, papules, or plaques distributed on the surface of limbs
- severe, relentless itching, and burning pain
Consequences
- chronic itching
- burning pain of the skin
- disturbed sleep
- affection of mental health
- reduced quality of life
Why the study is being conducted?
We are looking for participants for our study who suffer from the symptoms listed. The aim of the study is to evaluate the effect of the investigational drug to be tested on Prurigo Nodularis and the change in quality of life for you as a patient. During the course of the study, you will receive comprehensive and study-related treatment from our medical specialists.
Important information
Study treatment and time required
The patients are randomly divided into three groups. There are two different dosage forms. Group 1 receives low dose; group 2 receives high dose and there is also a placebo group. The patients of the placebo group will receive the active substance during the extension period of the treatment phase. The active substance and placebo is administered orally as a tablet. The study will be conducted in three phases:
- Preliminary examination: up to 4 weeks before the start of treatment (1 visit to the study site)
- Treatment phase: core period of 16 weeks (6 visits) and extension period of 24 weeks (7 visits)
- Follow-up care: 4 weeks (1 visit)
The total duration of the study is approximately 12 months (48 weeks) and includes 15 visits to the study site. All participants are monitored by medical professionals throughout the course of the study and are examined at regular intervals.
What is Prurigo Nodularis?
Prurigo Nodularis is a chronic inflammatory skin disease that persistently causes intense itching and skin papules or nodules on certain areas of the skin – especially on arms, legs, or trunk. The disease can occur at any age but is more commonly observed in middle-aged to elderly individuals and people with colored skin. Prurigo Nodularis is not contagious.
Requirements for participation
You are suitable if you:
- are at least 18 years old
- have been suffering from Prurigo Nodularis for at least 3 months
- have at least 20 lesions on the entire body
- have already been pre-treated with topical corticosteroids (without sufficient effect or with intolerance)
Excluded from participation are persons who:
- have a documented atopic dermatitis (AD) severity moderate to severe recently
- are infected with hepatitis B, hepatitis C or the human immunodeficiency virus
- have other uncontrolled or serious disease
- are currently pregnant, breastfeeding or planning to become pregnant in the near future