Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06966479 | A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR) | PHASE2 | ACTIVE NOT_RECRUITING | 396 | — | — | May 21, 2025 | Sep 1, 2027 | May 14, 2026 | 102 | United States, Argentina +13 |
| NCT06196879 | A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT) | PHASE2 | COMPLETED | 479 | — | — | Feb 27, 2024 | Mar 19, 2026 | May 1, 2026 | 155 | United States, Argentina +13 |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 48. |
| Name | Type | Description |
|---|---|---|
| Verekitug | DRUG | Verekitug subcutaneous injection. |
| Placebo | DRUG | Verekitug matching placebo. |
| Verekitug (UPB-101) | DRUG | Verekitug (UPB-101) formulated solution |
Inclusion Criteria: 1. Completion of the VALIANT study (UPB-CP-04 \[NCT06196879\]) per protocol. 2. Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study. 3. Contra...