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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eli Lilly & Co.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

21 Oct 2024 → ongoing

Decision date (initial)

2024-07-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Eli Lilly and Company

External identifiers

EU CT number

2023-508760-29-00

WHO UTN

U1111-1303-8343

ClinicalTrials.gov

NCT06338995

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Conditions and MedDRA coding

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 2

1. 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.
2. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 1. Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity
2. 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. [Time Frame: Baseline, Week 24]
3. 2. Mean CFBL in Endoscopic Nasal Polyp Score (NPS) 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. [Time Frame: Baseline, Week 24]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation

Eli Lilly & Co.

Address

1 Lilly Corporate Center

City

Indianapolis

Postcode

46285-0001

Country

United States

Scientific contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Public contact point

Organisation

Eli Lilly & Co.

Contact name

Lilly Clinical Trials information desk

Third parties 8

Locations

11 EU/EEA countries · 62 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 189 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications