Nasal PolyposisPhase 2NCT02734849

Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

A Phase 2 study testing AK001 low dose and AK001 high dose in people with Nasal Polyposis, run by Allakos Inc. at 15 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Nasal Polyposis
What is being tested?: AK001 low dose and AK001 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 15 sitesin 6 countries
Study dates: Apr 2016to Jan 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

15 sites in 6 countries.

Country

City, postcode or hospital

15 sites in 6 countries

United States5 sites

Investigator site
Boston, Massachusetts, 02101
Investigator site
Charlottesville, Virginia, 22901
Investigator site
Chicago, Illinois, 60007
Investigator site
Houston, Texas, 77001
Investigator site
Pittsburgh, Pennsylvania, 15106

Other trials in United States

Spain3 sites

Investigator site
Barcelona
Investigator site
Jerez de la Frontera
Investigator
Valencia

Other trials in Spain

Belgium2 sites

Investigator site
Ghent
Investigator site
Leuven

Other trials in Belgium

Germany2 sites

Investigator site
Düsseldorf
Investigator site
Münster

Other trials in Germany

United Kingdom2 sites

Investigator site
Cambridge
Investigator site
Manchester

Other trials in United Kingdom

Netherlands1 site

Investigator site
Amsterdam

Other trials in Netherlands

About this study

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

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

Read the detailed description

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

Conditions: Nasal Polyposis
Being tested: AK001 low dose, AK001 high dose, Placebo
Medical subject headings: Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AK001 low doseDrug
25 mg AK001 will be administered as multiple doses
AK001 high doseDrug
250 mg AK001 will be administered as multiple doses
PlaceboDrug
Placebo will be administered as multiple doses

Study groups in NCT02734849
Study group	Role	What they receive
25 mg AK001	Experimental	25 mg AK001 will be administered as multiple doses Receives: Drug: AK001 low dose
250 mg AK001	Experimental	250 mg AK001 will be administered as multiple doses Receives: Drug: AK001 high dose
Placebo	Placebo comparator	A placebo comparator consisting of inactive excipients will be administered as multiple doses Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Polys Score (TPS)
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.
Measured: From Baseline (prior to the first dose) to Week 12 (Day 84)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Jan 2018

First posted12 Apr 2016 (estimated)
Study startApr 2016
Primary completionJan 2018
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nasal PolyposisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02734849
Sponsor's protocol ID: AK001-002
Status last verified: Dec 2018
First submitted: 24 Mar 2016
Last updated: 25 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
RecruitingObservational study
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps

All Nasal Polyposis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
ClinicalTrials.gov ID: NCT02734849
Acronym / sponsor ID: AK001-002
Conditions: Nasal Polyposis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Allakos Inc.Industry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: Jan 2018 (actual)
Study completion: Jan 2018 (actual)
First posted: 12 Apr 2016 (estimated)
Results: Posted 28 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
25 mg AK001	Experimental	Drug: AK001 low dose25 mg AK001 will be administered as multiple doses
250 mg AK001	Experimental	Drug: AK001 high dose250 mg AK001 will be administered as multiple doses
Placebo	Placebo comparator	Drug: PlaceboA placebo comparator consisting of inactive excipients will be administered as multiple doses

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AK001 low dose25 mg AK001 will be administered as multiple doses	Drug	25 mg AK001
AK001 high dose250 mg AK001 will be administered as multiple doses	Drug	250 mg AK001
PlaceboPlacebo will be administered as multiple doses	Drug	Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 28 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
25 mg AK001	16	12
250 mg AK001	14	14
Placebo	10	9

Primary outcome: Change in Total Polys Score (TPS)

Time frame: From Baseline (prior to the first dose) to Week 12 (Day 84). Mean (95% Confidence Interval). Unit: score on a scale

Measure	25 mg AK001 n = 15	250 mg AK001 n = 14	Placebo n = 10
Value	-0.5 (-1.3 to 0.3)	-0.3 (-1.1 to 0.5)	-0.2 (-1.1 to 0.7)

Population analysed: 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.

Adverse events

Time frame: The time of study drug administration until completion of the last study-related procedure at approximately 24 weeks, i.e. Day 168, or early termination of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
25 mg AK001	0 of 15 (0%)	11 of 15 (73.3%)	0 of 15
250 mg AK001	0 of 14 (0%)	10 of 14 (71.4%)	0 of 14
Placebo	0 of 10 (0%)	7 of 10 (70%)	0 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Nasal Polyposis

Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
RecruitingObservational study
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claus Bachert principal investigator

University Hospital, Ghent

15 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK001 low dose and AK001 high dose in people with Nasal Polyposis, run by Allakos Inc. at 15 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Spain, Belgium, Germany, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Polys Score (TPS) (time frame: From Baseline (prior to the first dose) to Week 12 (Day 84)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.