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A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
EU CTIS ID: 2023-508760-29-00
What this study is testing
1.To evaluate the efficacy of lebrikizumab compared to placebo in reducing nasal congestion severity and endoscopic nasal polyp score (NPS) on background intranasal corticosteroids (INCS) at Week 24. 2. This addendum is to be performed in selected sites in Poland, Germany, and Spain in addition to all procedures required by protocol J2T-MC-KGBU or any subsequent amendments to that protocol. The objective of this qualitative study is to explore participants’ experience with LY3650150 among a subset of adult participants with CRSwNP participating in the KGBU trial. These data will supplement the clinical data collected during the trial, with a focus to: understand the symptoms and impacts of CRSwNP, including those most important to trial participants, before the start of the study treatment, identify positive (improvement), neutral (no change), or negative (worsening) treatment effects on CRSwNP symptoms and impacts, including changes in symptom severity and impact bothersomeness, during the study treatment period and meaningfulness to trial participants, and explore trial participants’ treatment experience and perspective on treatment satisfaction
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP). 2. Prior treatment with systemic corticosteroids (SCS) for CRS or CRSwNP within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both. 3. 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. 4. Ongoing symptoms for at least 8 weeks prior to study entry (screening), including: a. 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 b. At least one other symptom, such as, but not limited to, partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea. 5. Patients 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
- 1. Have received a dose of lebrikizumab. 2. Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period. 3. 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) or may require a dose change during study. 4. Prior or current biologic treatment for CRSwNP and/or asthma and/or atopic dermatitis (AD), including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab. 5. Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit: a. B cell-depleting biologics, including rituximab, within 6 months. b. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. c. Systemic immunosuppressants within 4 weeks prior to baseline.
- 6. Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening 7. Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS 8. Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline: a. Nasal septal deviation occluding at least one nostril. b. Antrochoanal polyps. c. Acute sinusitis, acute nasal infection, or acute upper respiratory infection. d. Ongoing rhinitis medicamentosa. e. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young’s syndrome, primary ciliary dyskinesia, cystic fibrosis). f. A nasal cavity tumor (malignant or benign). g. Evidence of fungal rhinosinusitis. 9. Have anosmia from COVID or any reason other than CRSwNP. 10. Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening. 11. 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
- United States
- Japan
- Taiwan
- Korea, Republic of
- Canada
- Argentina
- United Kingdom
- China
- Mexico
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Japan; Taiwan; Korea, Republic of; Canada; Argentina and 3 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 EU CTIS; the study team decides eligibility.