Mepolizumab for the Treatment of Chronic Spontaneous Urticaria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03494881|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spontaneous Urticaria||Drug: Nucala||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Mepolizumab for the treatment of chronic spontaneous urticaria|
|Masking:||None (Open Label)|
|Official Title:||Mepolizumab for the Treatment of Chronic Spontaneous Urticaria: An Open-label, Single-arm, Exploratory Study|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||March 15, 2021|
|Estimated Study Completion Date :||June 15, 2021|
Experimental: Treatment Arm
This is an open-label pilot investigation and all study participants are assigned to active treatment. There is no placebo arm in this study.
All study participants will receive Nucala (2) 100mg SQ injections administered at two different anatomical sites at week zero, 2,4,6, and 8 for a total of 5 doses.
Other Name: Mepolizumab
- Mean UAS score 7 [ Time Frame: Study participants will document their CSU symptoms using a diary during the 10 week study period ]Study participants will document their CSU symptoms using a diary,daily scoring for a) the number of wheals [none (=0 points), <10 (=1 point), 10-50 (=2 points), or >50 per day (=3 points)], and b) the intensity of pruritus [none (=0 points), mild (=1 point), moderate (=2 points), severe (=3 points)]. The daily UAS score is summed over a week to calculate the UAS7 score (range: 0-42).
- Mean reduction in ISS and UCT [ Time Frame: 10 weeks of treatment with mepolizumab ]The weekly itch severity score is calculated using the pruritus score of the daily UAS score summed over a week (range: 0-21). The urticaria control test (UCT) is a more recently developed and validated outcome instrument to retrospectively assess urticaria control. Each UCT item has 5 answer options scored 0-4 with low points indicating high disease activity and low disease control. The minimum and maximum UCT scores are 0-16 with 16 points indicating complete disease control.
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): NCT03494881
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Laura Akhtar, BS 904-953-9648 Akhtar.Laura@mayo.edu|
|Principal Investigator: Jason C Sluzevich|
|Principal Investigator:||Jason C Sluzevich, M.D.||Study Principal Investigator|