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OpenTrials
Completed

NCT Number: NCT02734849

Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

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Key information

Conditions

Nasal Polyposis Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator site, Ghent, Belgium

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About this study

AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale
  • History of sinusitis symptoms
  • SNOT-22 ≥30
  • No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings

Exclusion criteria

  • Use of systemic corticosteroids within 6 weeks of screening
  • Chronic use of antibiotic therapy within 3 months prior to Screening
  • Nasal surgery (including polypectomy) within 6 months prior to Screening
  • Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer

Treatment and study plan

AK001 low dose

Drug

25 mg AK001 will be administered as multiple doses

AK001 high dose

Drug

250 mg AK001 will be administered as multiple doses

Placebo

Drug

Placebo will be administered as multiple doses

Primary outcomes

  1. Change in Total Polys Score (TPS)

    Time frame: From Baseline (prior to the first dose) to Week 12 (Day 84)

    NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Change in TPS from Baseline (prior to the first dose) to Week 12 (Day 84) was the primary outcome of the study. TPS ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps, a higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Allakos Inc.

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2016
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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