Verekitug for Asthma
Recruiting at 1 trial location
UB
Overseen ByUpstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Upstream Bio Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).
Research Team
JC
James C Lee, MD
Principal Investigator
Upstream Bio
Eligibility Criteria
This trial is for adults who have severe asthma and completed the VALIANT study. Participants must consent to long-term follow-up and agree to use contraception according to local regulations.Inclusion Criteria
I completed the VALIANT study as required.
I have signed and received a copy of the consent form for the study.
I am following local laws on birth control for clinical study participants.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive verekitug (UPB-101) and placebo injections every 12 or 24 weeks for up to 48 weeks
48 weeks
Injections at Weeks 12, 24, 36, and 48
Follow-up
Participants are monitored for safety and effectiveness after treatment
16 weeks
Treatment Details
Interventions
- Verekitug
Trial Overview The trial is testing Verekitug (UPB-101) against a placebo in people with severe asthma, focusing on its safety and effectiveness over an extended period after they've finished the initial VALIANT study.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Verekitug 400 mg Q24W and PlaceboExperimental Treatment2 Interventions
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.
Group II: Verekitug 100 mg Q12W and PlaceboExperimental Treatment2 Interventions
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.
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Who Is Running the Clinical Trial?
Upstream Bio Inc.
Lead Sponsor
Trials
4
Recruited
570+
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