Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Verekitug · 4 trials · 3 indications
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours.
Bilateral endoscopic NPS is a physician-reported scoring system to estimate the extent or severity of nasal polyps (NPs) based on assessments by nasal endoscopy. Each nostril is scored on a categorical scale of 0 to 4. The total score is the sum of the right and left scores (0-8). A higher score means severe disease.
| Arm | Type | Description |
|---|---|---|
| Verekitug (UPB-101) 100 mg and Placebo | EXPERIMENTAL | Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96. |
| Verekitug (UPB-101) 400 mg and Placebo | EXPERIMENTAL | Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96. |
| Verekitug 100 mg Q12W and Placebo | EXPERIMENTAL | Participants will receive 0.5 mL of verekitug (100 mg) and 2.0 mL of matching placebo, subcutaneous (SC) injections, every 12 weeks (Q12W) for up to 48 weeks. |
| Verekitug 400 mg Q24W and Placebo | EXPERIMENTAL | Participants will receive 2.0 mL of verekitug (400 mg) and 0.5 mL of matching placebo, SC injections, at Weeks 24 and 48 visits. Participants will also receive 2.0 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. |
| Verekitug (UPB-101): 100 mg Q12W / Placebo | EXPERIMENTAL | Participants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48. |
| Verekitug (UPB-101): 400 mg Q24W / Placebo | EXPERIMENTAL | Participants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. |
| Verekitug (UPB-101): 100 mg Q24W / Placebo | EXPERIMENTAL | Participants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. |
| Verekitug (UPB-101) | EXPERIMENTAL | Participants will be administered 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) subcutaneously, every 12 weeks for 24 weeks. |
| Matching placebo | PLACEBO_COMPARATOR | Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Verekitug | DRUG | Verekitug (UPB-101) formulated solution |
| Placebo | OTHER | Matching Placebo to Verekitug (UPB-101) |
| Verekitug (UPB-101) | DRUG | Verekitug (UPB-101) formulated solution |
Inclusion Criteria: * Physician diagnosis of COPD for \>12 months. * Current or former smokers with a smoking history of 10 pack-years or more. * Post-bronchodilator FEV1/ Forced Vital Capacity (FVC) ratio \<0.70 and predicted post-bronchodilator FEV1 \>30% and ≤80%. * Modified Medical Research Cou...