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New treatment option for Perennial Allergic Rhinitis (PAR)
Official title A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
ClinicalTrials.gov ID: NCT06339008
What this study is testing
What is LY3650150?
LY3650150 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for perennial allergic rhinitis (par).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. Participants can expect study participation to last up to 29.5 months.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Physician-diagnosed perennial allergic rhinitis (PAR).
- Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70...
- The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum...
- A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum...
- Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
You likely can't join if
- Have received a dose of lebrikizumab.
- Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual...
- Have received treatment with any rescue medication during the run-in period.
- Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or...
- Any current or prior use of biologics indicated for asthma or AD are prohibited.
- B cell-depleting biologics, including rituximab, within 6 months.
See the full eligibility criteria
- Physician-diagnosed perennial allergic rhinitis (PAR).
- Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
- The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test.
- A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
- Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
- Have received a dose of lebrikizumab.
- Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.
- Have received treatment with any rescue medication during the run-in period.
- Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:
- Any current or prior use of biologics indicated for asthma or AD are prohibited.
- B cell-depleting biologics, including rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline.
- Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period.
- Anticipates significant changes in their daily environmental exposure.
- Has a known history of recurrent acute or chronic sinusitis.
- Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Huntington Beach, California, United States
- Inglewood, California, United States
- Laguna Niguel, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- River Forest, Illinois, United States
- Lexington, Kentucky, United States
- Ypsilanti, Michigan, United States
- Minneapolis, Minnesota, United States
- Columbia, Missouri, United States
- St Louis, Missouri, United States
- Bellevue, Nebraska, United States
- Belleville, New Jersey, United States
- Hamilton, New Jersey, United States
- Teaneck, New Jersey, United States
- Horseheads, New York, United States
- Asheville, North Carolina, United States
+ 42 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntington Beach, California, United States; Inglewood, California, United States; Laguna Niguel, California, United States; San Diego, California, United States; Colorado Springs, Colorado, United States; Tallahassee, Florida, United States and 56 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.