A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps



Sponsors

Lead Sponsor



Source

Hoffmann-La Roche

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief Summary

The purpose of this study is to determine the efficacy and safety of omalizumab compared with
placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have
had an inadequate response to standard-of-care treatments.

Overall Status

Not yet recruiting

Start Date

2017-10-27

Completion Date

2019-05-10

Primary Completion Date

2019-05-10

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24
Baseline, Week 24
Change From Baseline in Nasal Polyp Score (NPS) to Week 24
Baseline, Week 24

Secondary Outcome

Measure

Time Frame

Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) at Week 24
Baseline, Week 24
Change From Baseline in Average Daily Sense of Smell Score at Week 24
Baseline, Week 24
Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24
Baseline, Week 24
Change From Baseline in Average Daily Anterior Rhinorrhea Score at Week 24
Baseline, Week 24
Change From Baseline in Participant Reported Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 at Week 24
Baseline, Week 24
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) at Week 24
Baseline, Week 24
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) of >= 0.5 (in participants with comorbid asthma only) at Week 24
Baseline, Week 24
Change From Baseline in Average Daily NCS at Week 16
Baseline, Week 16
Change From Baseline in NPS at Week 16
Baseline, Week 16
Percentage of Participants With Reduction in the Need for Surgery by Week 24, as Defined by an NPS of <= 4 (Unilateral Score of <= 2 on Each Side) and Improvement in SNOT-22 Score of >= 8.9
Up to Week 24
Percentage of Participants Requiring of Rescue Treatment (Systemic corticosteroid {CS} For >= 3 Consecutive Days) or Having had Surgery for Nasal Polyps through Week 24
Up to Week 24
Percentage of Participants Requiring of Rescue Treatment (Systemic CS for >=3 Consecutive Days) Through Week 24
Up to Week 24
Percentage of Participants Having had Surgery for Nasal Polyps Through Week 24
Up to Week 24
Percentage of Participants With Adverse Events
Up to Week 28
Percentage of Participants With Serious Adverse Events
Up to Week 28
Percentage of Participants With Adverse Events Leading to Omalizumab/Placebo Discontinuation
Up to Week 28
Percentage of Participants With Clinically Significant Change in Laboratory Values
Up to Week 28
Serum Concentration of Omalizumab at Specified Timepoints
Day 1, Day 112, Day 168, Day 196
Serum Concentration of Total and Free Immunoglobulin E (IgE) at Specified Timepoints
Screening (Day -35), Day 1, Day 112, Day 168, Day 196

Enrollment

120

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

Omalizumab will be administered as a subcutaneous (SC) injection every 2 or 4 weeks.

Arm Group Label

Omalizumab


Intervention Type

Drug

Intervention Name


Description

Matching placebo will be administered as a SC injection every 2 or 4 weeks.

Arm Group Label

Placebo



Eligibility

Criteria

Inclusion Criteria:

- Age 18-75 years, inclusive, at time of signing Informed Consent Form.

- Ability to comply with the study protocol, in the investigator's judgment.

- Nasal polyp score (NPS) >= 5, with a unilateral score of >= 2 for each nostril, at
screening (Day -35), and on Day -7.

- Sino-Nasal Outcome Test-22 (SNOT-22) score >=20 at screening (Day -35) and at
randomization (Day 1).

- Treatment with at least nasal mometasone 200 micro gram per day, or equivalent daily
dosing of nasal corticosteroid (CS), for at least 4 weeks before screening (Day -35).

- Treatment with nasal mometasone 200 micro gram twice a day (BID) (or once a day [QD]
if intolerant to twice daily) during the run-in period with an adherence rate of at
least 70%.

- Presence of nasal blockage/congestion with NCS >=2 (1-week recall) at Day -35 and an
average of the daily NCS score over the 7 days prior to randomization of NCS >1 with
at least one of the following symptoms prior to screening: nasal discharge
(anterior/posterior nasal drip) and/or reduction or loss of smell.

- Eligibility per the study drug dosing table

- Willingness to maintain all background medications stable for the duration of the
treatment and follow-up periods.

- Willingness and ability to use electronic device to enter study-related information in
electronic devices (electronic diary [eDiary]/electronic tablet [eTablet]).

- Demonstration of at least 70% adherence to eDiary daily symptom assessment during run
in period, with fully completed entries on at least 4 days in the week prior to
randomization.

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use acceptable contraceptive methods during the treatment
period and for 60 days after the last dose of study drug.

Exclusion Criteria:

- Known history of anaphylaxis/hypersensitivity to omalizumab.

- Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is
longer) prior to screening (Day -35).

- Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab) for 6 months
prior to screening (Day -35).

- Current treatment with leukotriene antagonists/modifiers, unless participant has been
on stable dosing of such medication for at least 1 month prior to screening (Day -35).

- Treatment with non-steroid immunosuppressants within 2 months or 5 half-lives,
whichever is longer, prior to screening (Day -35).

- Treatment with systemic corticosteroids, except when used as treatment for nasal
polyposis, within 2 months prior to screening (Day -35).

- Usage of systemic CS during the run-in period. Participants requiring systemic CS
during run-in may be rescreened after completing systemic CS.

- Treatment with intranasal CS drops or CS administering devices (e.g., OptiNose device
or stents) within 1 month prior to screening (Day -35) or during the run-in period.

- History of nasal surgery (including polypectomy) within 6 months prior to screening.

- History of sinus or nasal surgery modifying the structure of the nose such that
assessment of NPS is not possible.

- Uncontrolled epistaxis requiring surgical or procedural intervention, including nasal
packing, within 2 months prior to screening.

- Known or suspected diagnosis of cystic fibrosis, primary ciliary dyskinesia (e.g.,
Kartagener syndrome) or other dyskinetic ciliary syndromes, hypogammaglobulinemia or
other immune deficiency syndrome, chronic granulomatous disease and granulomatous
vasculitis, granulomatosis with polyangiitis (e.g., Wegener's Granulomatosis), or
eosinophilic granulomatous with polyangiitis (EGPA) (e.g., Churg-Strauss syndrome).

- Presence of antrochoanal polyps.

- Concomitant conditions that interfere with evaluation of primary endpoint:

- Nasal septal deviation occluding one or both nostrils.

- Ongoing rhinitis medicamentosa.

- Acute sinusitis, nasal infection, or upper respiratory infection during the
run-in period.

- Known or suspected invasive or expansive fungal rhinosinusitis.

- Known HIV infection at screening.

- Known acute and chronic infections with hepatitis C virus (HCV) and hepatitis B virus
(HBV) at screening.

- Active tuberculosis requiring treatment within 12 months prior to screening (Day -35).

- Initiation of or change in allergen immunotherapy within 3 months prior to screening
(Day -35) or during the run-in period.

- Initiation of or change in aspirin desensitization within 4 months prior to screening
(Day -35) or during the run-in period.

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
60 days after the last dose of omalizumab.

- Current malignancy or history of malignancy within 5 years prior to screening, except
for appropriately treated carcinoma in situ of the cervix or non-melanoma skin
carcinoma that has been treated or excised and is considered resolved.

- Any serious medical condition (including but not limited to significant arrhythmia,
uncontrolled hypertension, significant pulmonary disease other than asthma) or
abnormality in clinical laboratory tests that precludes the participant's safe
participation in and completion of the study.

- History of alcohol, drug, or chemical abuse within 6 months of screening.

Gender

All

Minimum Age

18 Years

Maximum Age

75 Years

Healthy Volunteers

No


Overall Contact

Last Name

Reference Study ID Number: GA39688 www.roche.com/about_roche/roche_worldwide.htm

Phone

888-662-6728 (U.S. and Canada)

Email



Location

Facility

Status

University of Alabama at Birmingham
Birmingham Alabama 35294 United States
Not yet recruiting
Synexus - Clinical Research Advantage - Central Phoenix Medical Clinic LLC
Phoenix Arizona 85014 United States
Not yet recruiting
Synexus - Clinical Research Advantage, Inc. - Family Practice Specialists, LTD
Phoenix Arizona 85018 United States
Not yet recruiting
University of Arkansas for Medical Sciences
Little Rock Arkansas 72103 United States
Not yet recruiting
Jonathan Corren MD, Inc.
Los Angeles California 90025 United States
Not yet recruiting
Allergy and Asthma Associates of Southern California
Mission Viejo California 92691 United States
Not yet recruiting
The Allergy Station at Sacramento ENT
Roseville California 95661 United States
Not yet recruiting
Asthma & Allergy; Associates, P.C.
Colorado Springs Colorado 80907 United States
Not yet recruiting
Colorado Allergy & Asthma Centers, Pc
Denver Colorado 80230 United States
Not yet recruiting
Yale University School Of Medicine
New Haven Connecticut 06510 United States
Not yet recruiting
Empirical Research Group
Gainesville Florida 32653 United States
Not yet recruiting
Vitae Research Center
Miami Florida 33135 United States
Not yet recruiting
Asthma & Allergy of Idaho
Twin Falls Idaho 83301 United States
Not yet recruiting
Tandem Clinical Research, LLC
Marrero Louisiana 70072 United States
Not yet recruiting
FAAR Institute, LLC
Gaithersburg Maryland 20878 United States
Not yet recruiting
Montana Medical Research LLC
Missoula Montana 59808 United States
Not yet recruiting
Princeton Center For Clinical Research
Skillman New Jersey 08558 United States
Not yet recruiting
Northwell Health
Great Neck New York 11021 United States
Not yet recruiting
Montefiore Medical Center
The Bronx New York 10461 United States
Not yet recruiting
Thomas Jefferson University
Philadelphia Pennsylvania 19107 United States
Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania 15213 United States
Not yet recruiting
Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)
Warwick Rhode Island 02865 United States
Not yet recruiting
Medical University of South Carolina Hospital
Charleston South Carolina 29425 United States
Not yet recruiting
Northside Gastroenterology
Cypress Texas 77429 United States
Not yet recruiting
AARA Research Center - CRN
Dallas Texas 75231 United States
Not yet recruiting
Synexus - Clinical Research Advantage, Inc. - Doctors of Internal Medicine, Ltd
Plano Texas 75093 United States
Not yet recruiting
Synexus - Synexus US, LP - Plano
Plano Texas 75093 United States
Not yet recruiting
Jean Brown Research
Murray Utah 84123 United States
Not yet recruiting
Chrysalis Clinical Research
Saint George Utah 84790 United States
Not yet recruiting
St Paul's Hospital
Vancouver British Columbia V6Z 1Y6 Canada
Not yet recruiting
Lawson Health Research Institute
London Ontario N6A 4V2 Canada
Not yet recruiting
Ottawa Allergy Research Corp
Ottawa Ontario K1Y 4G2 Canada
Not yet recruiting
Hotel Dieu Du Centre Hospitalier de L'universite de Montreal; Pavillon Marie-Morin
Montreal Quebec H2W 1T8 Canada
Not yet recruiting
McGill University Health Center
Montreal Quebec H4A 3J1 Canada
Not yet recruiting
CHAUQ Hospital St Sacrement
Quebec G1S 4L8 Canada
Not yet recruiting
Fakultní nemocnice Brno Bohunice
Brno 625 00 Czechia
Not yet recruiting
Fakultni nemocnice u sv. Anny a Lekarska fakulta MU v Brne
Brno 656 91 Czechia
Not yet recruiting
Fakultni nemocnice Hradec Kralove
Hradec Kralove 500 05 Czechia
Not yet recruiting
Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov
Prostejov 796 04 Czechia
Not yet recruiting
Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde
Berlin 10117 Germany
Not yet recruiting
Synexus - Berlin
Berlin 12627 Germany
Not yet recruiting
Synexus - Bochum
Bochum 44787 Germany
Not yet recruiting
Universitätsklinikum Düsseldorf
Düsseldorf 40225 Germany
Not yet recruiting
IKF Pneumologie
Frankfurt am Main 60596 Germany
Not yet recruiting
HNO Zentrum Frankfurt
Frankfurt 60594 Germany
Not yet recruiting
Synexus - Leipzig
Leipzig 04103 Germany
Not yet recruiting
Universitätsklinikum Leipzig
Leipzig 04103 Germany
Not yet recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck 23538 Germany
Not yet recruiting
Hals-Nasen-Ohrenklinik und Poliklinik der TU München
München 81675 Germany
Not yet recruiting
Servicios Hospitalarios de Mexico SA de CV
Chihuahua 31238 Mexico
Not yet recruiting
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara 44100 Mexico
Not yet recruiting
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosi 78240 Mexico
Not yet recruiting
Synexus Affiliate - Clinic Med s.j. Bialystok
Białystok 15-879 Poland
Not yet recruiting
Synexus - Gdynia
Gdynia 81-384 Poland
Not yet recruiting
Centrum Medyczne Angelius Provita
Katowice 40-611 Poland
Not yet recruiting
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz 90-153 Poland
Not yet recruiting
Synexus - Poznan
Poznań 60-702 Poland
Not yet recruiting
Synexus - Warsaw
Warszawa 01-192 Poland
Not yet recruiting
Synexus - Wroclaw
Wrocław 50-088 Poland
Not yet recruiting
EMC Przychodnia przy ul. Łowieckie; Przychodnia przy ulicy Łowieckiej
Wrocław 50-220 Poland
Not yet recruiting
Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Serviços Farmacêuticos
Aveiro 3814-501 Portugal
Not yet recruiting
Hospital de Braga
Braga 4710-243 Portugal
Not yet recruiting
Hospital Senhora da Oliveira - Guimarães, E.P.E
Guimarães 4835-044 Portugal
Not yet recruiting
Hospital de Santa Maria
Lisboa 1649-035 Portugal
Not yet recruiting
Hospital Beatriz Ângelo
Loures 2674-514 Portugal
Not yet recruiting
Centro Hospitalar do Algarve - Hospital de Portimão
Portimão 8500-338 Portugal
Not yet recruiting
Moscow State Medical and Dental University named after A.I. Yevdokimov
Moscow Moskovskaja Oblast 111398 Russian Federation
Not yet recruiting
Federal State Educational Institution of Higher Education
Sankt-peterburg Sankt Petersburg 197022 Russian Federation
Not yet recruiting
Terapharm, Llc
Stavropol 355000 Russian Federation
Not yet recruiting
Yaroslavl Regional Clinical Psychiatry Hospital;
Yaroslavl 150003 Russian Federation
Not yet recruiting
Center for Reconstructive and Rehabilitation Medicine (University Clinic) of ONMedU
Odesa Crimean Regional Governmenta 65009 Ukraine
Not yet recruiting
Municipal Institution of Health Care; Regional Clinical Specialized Center of Radiation protection
Kharkiv Kharkiv Governorate 61166 Ukraine
Not yet recruiting
State Institution Institute of Otolaryngology n.a. Prof. O.S.
Kyiv Kiev Governorate 3680 Ukraine
Not yet recruiting
Ternopil Municipal City Hospital
Ternopil Podolia Governorate 46000 Ukraine
Not yet recruiting
University Clinic
Ivano-Frankivsk Poltava Governorate 76000 Ukraine
Not yet recruiting
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Poltava Poltava Governorate 36024 Ukraine
Not yet recruiting
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk 76014 Ukraine
Not yet recruiting
Kyiv City Clinical Hospital #9
Kyiv 04060 Ukraine
Not yet recruiting
Bradford Royal Infirmary
Bradford BD9 6RJ United Kingdom
Not yet recruiting
Darlington Memorial Hospital
Darlington DL3 6HX United Kingdom
Not yet recruiting
Victoria Hospital PPDS
Kirkcaldy KY2 5AH United Kingdom
Not yet recruiting
James Paget University Hospitals NHS Foundation Trust
Norfolk NR31 6LA United Kingdom
Not yet recruiting
Lister Hospital; Oncology Dept
Stevenage SG1 4AB United Kingdom
Not yet recruiting
Stepping Hill Hospital
Stockport SK2 7JE United Kingdom
Not yet recruiting
Sunderland Royal Hospital
Sunderland SR4 7TP United Kingdom
Not yet recruiting
Wigan,Wrighington & Leigh NHS Trust
Wigan WN1 2NN United Kingdom
Not yet recruiting

Location Countries

Country

Canada

Czechia

Germany

Mexico

Poland

Portugal

Russian Federation

Ukraine

United Kingdom

United States



Verification Date

2017-09-01

Lastchanged Date

2017-09-11

Firstreceived Date

2017-09-11

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Secondary Id

2017-001724-22

Number Of Arms

2

Intervention Browse

Mesh Term

Omalizumab


Arm Group

Arm Group Label

Omalizumab

Arm Group Type

Experimental

Description

Participants will receive Omalizumab every 2 weeks or every 4 weeks.


Arm Group Label

Placebo

Arm Group Type

Placebo Comparator

Description

Participants will receive matching placebo every 2 weeks or every 4 weeks.



Firstreceived Results Date

N/A

Acronym

POLYP 1

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)



ClinicalTrials.gov processed this data on September 13, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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