Oudallaye, Mbem-mbem, Salalatou, Doundé, Nianghana, Gassane, Senegal
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
Phase
3Span
147 weeksSponsor
Celldex TherapeuticsKrugersdorp, Gauteng
Recruiting
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Phase
3Span
128 weeksSponsor
Arrowhead PharmaceuticalsKrugersdorp, Gauteng
Recruiting
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
Phase
3Span
119 weeksSponsor
Arrowhead PharmaceuticalsKrugersdorp, Gauteng
Recruiting
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3)
Phase
3Span
175 weeksSponsor
Areteia TherapeuticsKrugersdorp
Recruiting
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Phase
3Span
219 weeksSponsor
Hoffmann-La RocheKrugersdorp
Recruiting
Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
The study will enroll participants with moderate to severe uncontrolled asthma who are on low-dose inhaled corticosteroid (ICS) - a long-acting beta-agonist (LABA) or medium-to-high-dose ICS with or without LABA background treatment. The study will be initiated by Lead-in pharmacokinetics (PK) cohort in asthma participants. Participant will be randomised globally, including participants in Lead-in PK cohort (2 arms) and in Part 1 of the study (2 arms). In the Lead-in PK cohort, participants will be randomised to Atuliflapon or placebo (recruitment completed). In Part 1 of the study, participants will be stratified by geographical region, and grouped based on high or low levels of biomarker at screening (Visit 1).
Phase
2Span
209 weeksSponsor
AstraZenecaKrugersdorp
Recruiting
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The study will consist of 3 periods: 1. Screening period (7 to 28 days) 2. Treatment period of 52 weeks 3. Safety follow-up period (7 to 14 days after the end of treatment [EOT] visit) Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period. This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.
Phase
3Span
178 weeksSponsor
AstraZenecaKrugersdorp
Recruiting
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Phase
3Span
151 weeksSponsor
Teva Branded Pharmaceutical Products R&D, Inc.Krugersdorp
Recruiting
Krugersdorp
Recruiting
Healthy Volunteers