Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Phase 2

Completed

• Conditions: Nasal Polyposis
• Interventions: Drug: AK001 low dose; Drug: AK001 high dose; Drug: Placebo

• Registration Number: NCT02734849
• Lead Sponsor: Allakos Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-03-24
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2018-12
• Disposition First Submitted: 2018-12-13
• Disposition First Submitted QC: 2018-12-13
• Disposition First Posted: 2018-12-17
• Results First Submitted: 2020-12-02
• Results First Submitted QC: 2020-12-02
• Results First Posted: 2020-12-28
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg AK001	AK001 low dose	25 mg AK001 will be administered as multiple doses
250 mg AK001	AK001 high dose	250 mg AK001 will be administered as multiple doses
Placebo	Placebo	A placebo comparator consisting of inactive excipients will be administered as multiple doses

Primary Outcome Measures

Name	Time	Method
Change in Total Polys Score (TPS)	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.

Trial Locations

Locations (2)

Investigator site; 🇬🇧 Manchester, United Kingdom

Investigator; 🇪🇸 Valencia, Spain