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A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Efficacy and Safety Study of Lebrikizumab/ LY3650150 in Adults With Chronic Rhinosinusitis With Nasal Polyps on a Background Therapy With Intranasal Corticosteroids (J2T-MC-KGBU)

A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) (J2T-MC-KGBU)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Pending

Sept. 30, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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:

1. 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
2. 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.

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) or may require a dose change during study.
Prior or current biologic treatment for CRSwNP and/or asthma including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab.
Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:

1. B cell-depleting biologics, including rituximab, within 6 months.
2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
3. 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:

1. Nasal septal deviation occluding at least one nostril.
2. Antrochoanal polyps.
3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
4. Ongoing rhinitis medicamentosa.
5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis).
6. A nasal cavity tumor (malignant or benign).
7. 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.

Both

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Drug: LY3650150
Administered SC.
Drug: Placebo
Administered SC.
Drug: Standard therapy for INCS
Administered as intranasal spray.

[Study Arms]
Experimental: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Interventions:
Drug: LY3650150
Drug: Standard therapy for INCS
Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
Interventions:
Drug: LY3650150
Drug: Standard therapy for INCS
Placebo Comparator: Placebo Q2W/Q4W
Placebo will be given as SC injection. Participants will receive background therapy with INCS.
Interventions:
Drug: Placebo
Drug: Standard therapy for INCS

Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity [ Time Frame: Baseline, Week 24 ]
NCS severity is rated by study participants using a 4-point scale (range from 0 to 3), where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of nasal congestion for the previous 24 hours. This assessment will be collected in the participant eDiary.
Mean CFBL in Endoscopic Nasal Polyp Score (NPS) [ Time Frame: Baseline, Week 24 ]
The endoscopic NPS is assessed by a centralized, blinded, independent review of nasal endoscopy video recordings. The total score is the sum of the right and left nasal cavity scores. For each nasal cavity, endoscopic NPS is graded based on polyp size from 0 to 4, where 0 = no polyps and 4 = large polyps.

+81-3-6779-8166

Yes

Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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