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BioSolutions Open Protocol Summaries
INDICATION
AGE CRITERIA
DESCRIPTION
COPD
40-80
A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacyof Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)
Asthma
18-80
A Phase 2b, Randomised, Double-Blind, Placebo Controlled Dose Range Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily and Administered via the Saphira Device for 12-52 Weeks in Adults with Uncontrolled Moderate to Severe Asthma (LEVENT)
Lupus
18-75
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy
Axia Spondylarthritis
≥18 Yr Old
Phase II, Double Blind, Placebo Controlled, Randomized Study Examining Natrunix in combination with Standard of Care in HLA-B27 Positive Subjects with Axial Spondyloarthritis
Psoriatic Arthritis
≥18 Yr Old
A Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects with Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying with Active Psoriatic Arthritis Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs
Gout
≥ 18 to ≤ 85
A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants with Gout.
PRESTO
>40 to ≤ 85
A Multicentre, Parallel-group, Phase IIb, Randomised, Double‑blind, Placebo-controlled, 4-arm, 24-week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)
Chronic Low Back Pain
>40 to ≤ 85
Multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the full-spectrum Cannabis Extract VER-01 in patients with chronic low back pain (VERCLBP- 003)
Sjogren’s Disease
≥ 18 to < 75
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity.
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