Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Mouth and Tooth Diseases

Nasal Polyps

Colorectal Neoplasms

Nasopharyngeal Neoplasms

Polyps

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Nose Diseases

Respiratory Tract Diseases

Pathological Conditions, Anatomical

25 mg AK001 will be administered as multiple doses

250 mg AK001 will be administered as multiple doses

A placebo comparator consisting of inactive excipients will be administered as multiple doses

AK001 low dose

AK001 high dose

Placebo will be administered as multiple doses

Placebo

Claus Bachert

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

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

Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

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

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.

Allakos Inc.

If a patient completed the study with an ongoing adverse event (AE), investigational site personnel continued to follow-up until AE resolution and the documentation thereof. If, after 30 days from the study completion date, the AE was still continuing but not assessed as serious, the outcome was recorded as ongoing.

25 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.

25 mg AK001

250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.

250 mg AK001

Placebo was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Europe

Region of Enrollment

Total Polyp Score (TPS)

After 40 of the 70 patients planned were randomized in the study, enrollment was stopped as the Sponsor decided not to pursue further development of AK001. The study was not stopped for any safety concern. Early termination resulted uninterpretable data.

Henrik Rasmussen, MD, PhD, Chief Medical Officer

250 mg AK001 was administered as a single IV infusion through a peripheral vein on Days 0, 21, and 49

Modified Intent-to-Treat (MITT) population included all randomized subjects who have taken at least one dose of the study drug and had both a baseline and at least one post-baseline efficacy assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis	NCT02734849	Nasal Polyposis	AK001 low dose AK001 high dose Placebo	18 Years - 65 Years	Allakos Inc.
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis	NCT02734849	Nasal Polyposis	AK001 low dose AK001 high dose Placebo	18 Years - 65 Years	Allakos Inc.

Spots Global Cancer Trial Database for ak001 high dose