CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Dupilumab (SAR231893/REGN668)Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug232 Asthma reliever therapies Wiki 1.00
drug519 Cannabidiol Wiki 1.00
drug231 Asthma controller therapies (incl. prednisone/prednisolone) Wiki 1.00
drug1738 PLACEBO Wiki 0.71

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D001249 Asthma NIH 0.50

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002099 Asthma HPO 0.50

There is one clinical trial.

Clinical Trials


1 One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers.

NCT03560466 Asthma Drug: Dupilumab (SAR231893/REGN668) Drug: Asthma controller therapies (incl. prednisone/prednisolone) Drug: Asthma reliever therapies
MeSH:Asthma
HPO:Asthma

Primary Outcomes

Description: The number (n) and percentage (%) of patients experiencing any TEAE

Measure: Treatment-emergent adverse events (TEAEs)

Time: From Day 1 up to Week 64

Secondary Outcomes

Description: Annualized rate of severe asthma exacerbation events, during the treatment period

Measure: Severe asthma exacerbation events

Time: From Day 1 up to Week 52

Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline

Measure: Change in % predicted FEV1

Time: From Day 1 up to Week 64

Description: Change in absolute FEV1 - Clinically significant changes from baseline

Measure: Change in absolute FEV1

Time: From Day 1 up to Week 64

Description: Change in forced vital capacity (FVC)

Measure: Change in FVC

Time: From Day 1 up to Week 64

Description: Change in forced expiratory flow (FEF) 25-75%

Measure: Change in FEF

Time: From Day 1 up to Week 64

Description: Serum dupilumab concentrations - Changes from first dupilumab injection

Measure: Assessment of dupilumab concentration

Time: From Day 1 up to Week 64

Description: Titers of Anti-dupilumab antibodies

Measure: Assessment of immunogenicity

Time: From Day 1 up to Week 64

Description: Blood: Eosinophil count

Measure: Assessment of blood Eosinophil count

Time: From Day 1 up to Week 64

Description: Serum: total IgE

Measure: Assessment of total immunoglobulin E (IgE)

Time: From Day 1 up to Week 64


Related HPO nodes (Using clinical trials)