Characterization of the Inhibitory Effects of Fevipiprant (QAW039) on Activation of Eosinophils and ILC2 Cells by Prostaglandin D2 Metabolites

NCT03665701 | Completed

• 1 other identifier: 18-03 EONOV
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to draw blood from patients with well-defined atopic asthma that will be subsequently used in invitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2. The inhibitory activity of a potent DP2 receptor antagonist, Fevipripant, shall be determined.

Conditions

Atopic Asthma

Outcome Measures

Primary Outcomes (2)

• Cytokinesecretion without presence of Fevipiprant

  Cytokine release after exposure of ILC2 cells to prostaglandin D2

  4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2

• Cytokinesecretion with presence of Fevipiprant

  Cytokine release after exposure of ILC2 cells to prostaglandin D2

  4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2

Study Arms (1)

Inhibitory effects of Fevipiprant

EXPERIMENTAL

in vitro experiments: The reaction of the innate lymphoid cells by cytokine secretion in response to the stimulation by Prostagalandin D2 metabolites and the measurement of a potential suppressive effect of Fevipiprant will be assessed.

Procedure: Blood Sampling

Interventions

Blood Sampling PROCEDURE

Blood samples used within in vitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2.

Inhibitory effects of Fevipiprant

Eligibility Criteria

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

You may qualify if:

• Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
• Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
• Body weight ≥ 50 kg and BMI within the range 19-32 kg/m²
• History of allergic asthma since at least 12 months
• A concentration of at least 0,15 x 106/mL eosinophils in peripheral blood

You may not qualify if:

• History of an acute infection two weeks prior to the screening visit.
• Intake of oral steroids within 4 weeks prior to screening
• Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
• Participation in another clinical trial 30 days prior to enrollment.
• Donation of more than 100 ml of blood in the preceding 2 months before the screening visit.

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer ITEM im CRC

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 11, 2018
• Study Start: August 16, 2018
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)