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Characterization of the Inhibitory Effects of Fevipiprant (QAW039) on Activation of Eosinophils and ILC2 Cells by Prostaglandin D2 Metabolites (18-03 EONOV)

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ClinicalTrials.gov Identifier: NCT03665701
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fraunhofer-Institute of Toxicology and Experimental Medicine

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.

Condition or disease Intervention/treatment Phase
Atopic Asthma Procedure: Blood Sampling Not Applicable

Detailed Description:
The inhibitory activity of a potent DP2 receptor antagonist shall be determined. For these experiments eosinophil granulocytes and ILC2 cells will be isolated from the collected blood samples and used in specific assays in respect to their functional reactivity against the DP2 receptor antagonist Fevipiprant after respective stimulation using Prostaglandin D2 metabolites or Prostaglandin D2. Major rationale is to show and determine the EC70 of the effectivity of Fevipiprant against Prostaglandin D2 metabolite triggered activation of eosinophil granulocytes and ILC2 innate lymphoid cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of the Inhibitory Effects of Fevipiprant (QAW039) on Activation of Eosinophils and ILC2 Cells by Prostaglandin D2 Metabolites
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inhibitory effects of Fevipiprant
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
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.




Primary Outcome Measures :
  1. Cytokinesecretion without presence of Fevipiprant [ Time Frame: 4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2 ]
    Cytokine release after exposure of ILC2 cells to prostaglandin D2

  2. Cytokinesecretion with presence of Fevipiprant [ Time Frame: 4 hours after in-vitro exposure of ILC2 cells to prostaglandin D2 ]
    Cytokine release after exposure of ILC2 cells to prostaglandin D2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women will be considered for inclusion if they are:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665701


Locations
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Germany
Fraunhofer ITEM im CRC
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine

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Responsible Party: Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03665701     History of Changes
Other Study ID Numbers: 18-03 EONOV
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs