Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia

NCT02217332 | Completed Phase 2 Results

• 1 other identifier: KNS-76704-CS201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.

Conditions

Chronic Sinusitis With Nasal Polyps and Eosinophilia

Keywords

Sinusitis; Rhinosinusitis; CRS; CRSwNP; CSNP-E; Nasal polyps; Nasal polyposis; Eosinophilia; Asthma

Outcome Measures

Primary Outcomes (2)

• Ratio to Baseline in Peripheral Blood Eosinophil Counts After 6 Months of Treatment

  Change in peripheral blood eosinophil (measured in cells/μL) from baseline to month 6 is presented as ratio to baseline.

  Baseline and Month 6

• Change From Baseline in Total Polyp Score (TPS) After 6 Months of Treatment

  The change in Nasal Polyp Score (NPS) score after 6 months of treatment is presented. A blinded Central Endoscopy Rater determined the NPS for each nare on a scale of 0 to 4, and the bilateral NPS scores were added to generate the Total Polyp Score (TPS) on a scale of 0 to 8. A lower TPS corresponds to a lower polyp burden.

  Baseline and Month 6

Secondary Outcomes (5)

• Number of Subjects With Potentially Clinically Significant Values in Clinical Laboratory Evaluations

  6 months

• Number of Subjects With Potentially Clinically Significant Values in Vital Signs and Weight

  6 months

• Number of Subjects With Potentially Significant Values in Electrocardiogram Parameters

  6 months

• Ratio to Baseline in Peripheral Blood Eosinophil Counts After 3 Months of Treatment

  Baseline and Month 3

• Change From Baseline in TPS After 3 Months of Treatment

  Baseline and Month 3

Other Outcomes (1)

• Ratio to Baseline in Polyp Tissue Eosinophil Count After 6 Months of Treatment

  Baseline and Month 6

Study Arms (1)

dexpramipexole

EXPERIMENTAL

dexpramipexole 150 mg BID

Drug: dexpramipexole

Interventions

dexpramipexole DRUG

Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)

Also known as: KNS-760704, BIIB050, RPPX

dexpramipexole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>18 or \<70 years of age
• Willing to practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after the last dose of study treatment
• Confirmed diagnosis of chronic sinusitis with nasal polyps
• Documented history of nasal eosinophilia
• Documented peripheral absolute eosinophil count \>300 cells/μL
• Bilateral total polyp score of \>4
• Sino-nasal outcome test (SNOT-22) score of \>7
• Using an intranasal corticosteroid spray or irrigation (\< 1000 μg/day beclomethasone or equivalent)

You may not qualify if:

• Acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within 2 weeks prior to baseline
• CT scan suggestive of allergic fungal rhinosinusitis
• Nasal septal deviation that would occlude at least one nostril
• Nasal surgery (including polypectomy) within 6 months prior to baseline
• History of more than 5 sinonasal surgeries requiring general anesthesia
• History of more than 2 sinonasal surgeries that changed the lateral wall of the nose
• History of cystic fibrosis, primary ciliary's dysfunction or Kartagener's syndrome
• History of diagnosis with a parasitic infection
• Hospitalization or emergency treatment for the treatment of asthma two or more times in the 12 months prior to baseline
• Hospitalization for an acute asthmatic attack within 4 weeks prior to baseline
• Forced expiratory volume (FEV1) of \<60% of predicted normal range
• Treatment with a systemic corticosteroid or intra-polyp corticosteroid within 8 weeks prior to baseline or anticipated need for systemic corticosteroids during the study treatment period
• Utilization of rescue oral corticosteroids for asthma or chronic sinusitis exacerbation more than one time within the past 1 year
• Treatment with an investigational drug in the previous 30 days or 5-half-lives, whichever is longer
• Treatment with a monoclonal antibody therapy including omalizumab (Xolair®), within 5-half-lives

Sponsors & Collaborators

• Knopp Biosciences: lead

Study Sites (7)

ENT Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Eosinophilia; Sinusitis; Rhinosinusitis; Nasal Polyps; Asthma

Interventions

Dexpramipexole

Condition Hierarchy (Ancestors)

Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Head of Regulatory
• Organization: Knopp Biosciences

greg@knoppbio.com

4124881776

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 14, 2016
• Study Completion: January 20, 2017
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Locations

US (7)