A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis

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

8 Oct 2024 → ongoing

Decision date (initial)

2024-08-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Eli Lilly and Company

External identifiers

EU CT number

2023-508817-18-00

WHO UTN

U1111-1303-8357

ClinicalTrials.gov

NCT06339008

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of lebrikizumab up to Week 16 on total nasal symptoms compared with Placebo

Conditions and MedDRA coding

Perennial Allergic Rhinitis (PAR)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. • Physician-diagnosed PAR.
2. • 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).
3. • A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive antigen-specific IgE test.
4. • Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.

Exclusion criteria 8

1. • Have received a dose of lebrikizumab.
2. • Is currently on allergen immunotherapy (AIT). However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.
3. • Have received treatment with any rescue medication during the run-in period.
4. • Have received treatment with any biologic or systemic immunosuppressants, including Janus kinase inhibitors for inflammatory disease or autoimmune disease prior to baseline visit: a. Any current or prior use of biologics indicated for asthma or AD are prohibited. b. B cell-depleting biologics, including rituximab, within 6 months. c. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer. d. Systemic immunosuppressants, including Janus kinase inhibitors, within 4 weeks prior to baseline.
5. • 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.
6. • Anticipates significant changes in their daily environmental exposure
7. • Has a known history of recurrent acute or chronic sinusitis
8. • 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 1

1. 1. Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16 Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. [Time Frame: Baseline, Week 16]

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

3 EU/EEA countries · 24 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 71 files

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

Application history

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