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New treatment option for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Official title A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
ClinicalTrials.gov ID: NCT06338995
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 chronic rhinosinusitis with nasal polyps (crswnp).
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 participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 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 12 and older
You may be able to join if
- Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).
- Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for...
- Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.
- Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:
- Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to...
You likely can't join if
- Have received a dose of lebrikizumab.
- Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.
- Allergen immunotherapy (subcutaneous immunotherapy [SCIT]/sublingual immunotherapy [SLIT]) initiated within 6 months prior to screening, that is not...
- Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or...
- Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
- B cell-depleting biologics, including rituximab, within 6 months.
See the full eligibility criteria
- Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).
- Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.
- Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.
- Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:
- Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and
- At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.
- Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
- Adolescent participants ≥12 to \<18 years of age and weighing ≥40 kg at time of Visit 1.
- Have received a dose of lebrikizumab.
- Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.
- Allergen immunotherapy (subcutaneous immunotherapy [SCIT]/sublingual immunotherapy [SLIT]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).
- Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.
- Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
- 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 within 4 weeks prior to baseline.
- Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening
- Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS
- Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:
- Nasal septal deviation occluding at least one nostril.
- Antrochoanal polyps.
- Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
- Ongoing rhinitis medicamentosa.
- Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for...
- A nasal cavity tumor (malignant or benign).
- Evidence of fungal rhinosinusitis.
- Have anosmia from COVID or any reason other than CRSwNP.
- Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.
- 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
- Birmingham, Alabama, United States
- Huntsville, Alabama, United States
- Tucson, Arizona, United States
- Arcadia, California, United States
- Irvine, California, United States
- La Mesa, California, United States
- Long Beach, California, United States
- Roseville, California, United States
- Torrance, California, United States
- Colorado Springs, Colorado, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pompano Beach, Florida, United States
- Tampa, Florida, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Overland Park, Kansas, United States
- Mandeville, Louisiana, United States
- White Marsh, Maryland, United States
- Boston, Massachusetts, United States
+ 145 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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Huntsville, Alabama, United States; Tucson, Arizona, United States; Arcadia, California, United States; Irvine, California, United States; La Mesa, California, United States and 159 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.