Clinical & Genetics Research in Allergic & Immunologic Disease
Current Clinical Trial Offerings
PI: Giselle Mosnaim, MD, MS
The Clinical and Genetics Research in Allergic & Immunologic Disease program’s overarching goal is to improve the lives of people living with Allergic & Immunologic disease.
We conduct clinical trials in new therapeutic, diagnostic tools, and devices in:
- Chronic Spontaneous Urticaria
- Asthma
Our team is comprised of a team of board-certified Allergist & Immunologist, research nurses & research coordinators. Our team collaborates with the University of Chicago Pritzker School of Medicine and Harvard School of Medicine.
Providers can refer patients to an enrolling trial or to our research volunteer database where they will be contacted about upcoming trials. Please refer to gmosnaim@northshore.org or EPIC message Dr. Giselle Mosnaim.
ENROLLING NOW:
GSK Nimble – Assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or Benralizumab.
Population: Adults and adolescents ³12 years of age, asthma for ≥2 years, Receiving either mepolizumab 100 mg SC or benralizumab 30 mg SC for ≥12 months.
Design: A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study
Duration: 1 year and 3 months, 18 clinical visits
Stipend: Free medication, no insurance needed, $62 compensation per complete visit
Contact: acarrasquel@northshore.org or 847-663-8530
Sanofi LPS – Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients with Uncontrolled Moderate to Severe Asthma.
Population: Adults and adolescents ³18 years of age, asthma for ≥2 years, treatment with ICS, FEV1 < 80%, ≥1 severe exacerbation in the previous year.
Design: Randomized, Double-Blind, Placebo controlled Study
Duration: 3 years, 15 clinical visits
Stipend: Free medication, no insurance needed, $50 compensation per complete visit
Contact: acarrasquel@northshore.org or 847-663-8530
Incyte Asthma – Evaluating the effect of 3 dosing regimens of povorcitinib on pulmonary function in adults with moderate to severe uncontrolled asthma after 24 weeks.
Population: Adults 18-65 years of age, asthma ≥1 year, documented history of ≥2 severe asthma exacerbations in the past 12 months, FEV1 <80% predicted, ACQ-5 score ≥1.5 during screening assessment despite taking a medium to high dose ICS-LABA
Design: Multicenter, double-blind, randomized, placebo-controlled, dose-ranging Phase 2 study
Duration: 14 months, 19 clinical visits
Stipend: Free medication, no insurance needed, $30-$40 compensation per complete on-site visit
Contact: tewing@northshore.org or 847-663-8530
Teva Flair – Demonstrating the efficacy of high dose and low dose fluticasone propionate/albuterol sulfate integrated electronic module multi-dose dry powder inhaler (eMDPI) compared to albuterol sulfate-only eMDPI in decreasing severe asthma exacerbations when used as a rescue medication.
Population: Adults and adolescents ³18 years of age, asthma ≥1 year, documented history of ≥1 severe asthma exacerbation in the past 12 months, ≥12% reversibility, ACQ-5 score ≥1.5 during screening assessment despite taking a stable dose of prescribed inhaled asthma controller medications
Design: A randomized, double-blind, multicenter, active-controlled, parallel-group Phase 3 study
Duration: On-site visits every 3 months, with monthly phone calls in between visits. Because this is an event-driven study there is no set duration; the study will continue until a predetermined number of severe asthma exacerbations have occurred – possibly 36 months.
Stipend: Free medication, no insurance needed, $75 compensation per complete on-site visit
Contact: tewing@northshore.org or 847-663-8530
Novartis CSU Wearable – Ambulatory blood pressure monitoring in adult patients with chronic spontaneous urticaria inadequately controlled by H1-antihistamines treated with remibrutinib.
Population: Adults and adolescents ³18 years of age, CSU duration for ≥ 6 months, CSU inadequately controlled by second generation H1-AH, no ongoing or part history of hypertension, participants able to wear 24-hour ambulatory blood pressure measurement in 2 different visits of the study.
Design: A multicenter, open-label Phase 3 study
Duration: 6 months, 8 clinical visits
Stipend: Free medication, no insurance needed, $70 compensation per complete visit
Contact: acarrasquel@northshore.org or 847-663-8530
Novartis CSU Adolescent – Assessing the efficacy, pharmacokinetics, and safety of remibrutinib vs placebo after 12 weeks of treatment in adolescents with chronic spontaneous urticaria not adequately controlled by H1-anthihistamines.
Population: Adolescents 12-18 years of age, CSU duration for ≥ 6 months, CSU inadequately controlled by second generation H1-AH
Design: Global, multi-center, randomized, double-bind, parallel-group, placebo-controlled Phase 3 study
Duration: 8 months, 10 clinical visits
Stipend: Free medication, no insurance needed, $102 compensation per complete visit
Contact: acarrasquel@northshore.org or 847-663-8530
Novartis CINDU – Evaluating the efficacy, safety, and tolerability of remibrutinib vs placebo over 52 weeks in adults suffering from chronic inducible urticaria (CINDU, subtypes: symptomatic dermographism, cold urticaria, or cholinergic urticaria) inadequately controlled by H1-antihistamines.
Population: Adults and adolescents ³18 years of age, diagnosis with one of three CINDU subtypes (symptomatic dermographism, cold urticaria, or cholinergic urticaria) with duration for ≥4 months, inadequately controlled by second generation H1-AH
Design: Global, multi-center, randomized, double-bind, placebo-controlled Phase 3 study
Duration: 14 months, 13 clinical visits
Stipend: Free medication, no insurance needed, $52 compensation per complete visit
Contact: acarrasquel@northshore.org or 847-663-8530