Chronic Rhinosinusitis With Nasal PolypsPhase 1NCT02170337
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
A Phase 1 study testing AMG 282 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Amgen at 4 sites in United States.
Trial summary
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- AMG 282
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2014to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive
- diagnosis of CRSwNP (inflammation of the nose and paranasal sinuses characterized in adults by 2 or more symptoms, 1 of which should be either nasal blockage or nasal discharge and/or facial pain and/or reduced smell for greater than 12 weeks)
- bilateral nasal polyps of grade 3 or 4
Who cannot join
- subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
- Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP):
- Forced Expiratory Volume (FEV1) </= 70%
- Asthma exacerbation requiring systemic corticosteroid treatment or hospitalization for > 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Aurora, Colorado, 80045
Research Site
Houston, Texas, 77030
Research Site
Santa Monica, California, 90404
Research Site
South Miami, Florida, 33143
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- AMG 282, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 282Drug
AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps
PlaceboDrug
Contains no active drug
| Study group | Role | What they receive |
|---|---|---|
| AMG 282 | Experimental | AMG 282 administered as subcutaneous and intravenous doses. Receives: Drug: AMG 282 |
| Placebo | Placebo comparator | No active drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
Measured: 169 days
Immunogenicity
Subject incidence of anti-AMG 282 antibodies
Measured: 169 days
Secondary outcomes (1)
Pharmacokinetic profile of AMG 282
Serum concentrations and derived PK parameters (eg, time to maximum concentration [tmax], area under the concentration-time curve over the dosing interval τ [AUCτ] after the first and last dose, and maximum observed concentration [Cmax]).
Measured: 169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170337
- Sponsor's protocol ID
- 20110236
- Status last verified
- May 2016
- First submitted
- 19 Jun 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang W, Cheung D, Fong A, Brooks L, Grimbaldeston MA, Arjomandi A, Yang X, Dash A, Wong H, Parnes JR, Mohan D. Safety, Pharmacokinetics, and Immunogenicity of Astegolimab, an Anti-ST2 Monoclonal Antibody, in Randomized, Phase I Clinical Studies. Clin Transl Sci. 2025 Oct;18(10):e70338. doi: 10.1111/cts.70338.
PubMed 41036707
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT02170337
- Acronym / sponsor ID
- 20110236
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects with chronic rhinosinusitis with nasal polyps
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMG 282 | Experimental | Drug: AMG 282AMG 282 administered as subcutaneous and intravenous doses. |
| Placebo | Placebo comparator | Drug: PlaceboNo active drug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and females witha BMI between 18.0 and 32.0 kg/m2, inclusive
- diagnosis of CRSwNP (inflammation of the nose and paranasal sinuses characterized in adults by 2 or more symptoms, 1 of which should be either nasal blockage or nasal discharge and/or facial pain and/or reduced smell for greater than 12 weeks)
- bilateral nasal polyps of grade 3 or 4
Key exclusion criteria (4 listed)
- subject with evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
- Forced Expiratory Volume (FEV1) </= 70%
- Asthma exacerbation requiring systemic corticosteroid treatment or hospitalization for > 24h for treatment of asthma, within 3 months prior to screening or are on a dose of greater than 1000 μg fluticasone.
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 |
|---|---|---|
| AMG 282AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps | Drug | AMG 282 |
| PlaceboContains no active drug | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: 169 days
Subject incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECGs)
Immunogenicity
Time frame: 169 days
Subject incidence of anti-AMG 282 antibodies
1 secondary outcome
Pharmacokinetic profile of AMG 282
Time frame: 169 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Derived from this study: PubMed 41036707Zhang W, Cheung D, Fong A, Brooks L, Grimbaldeston MA, Arjomandi A, Yang X, Dash A, Wong H, Parnes JR, Mohan D. Safety, Pharmacokinetics, and Immunogenicity of Astegolimab, an Anti-ST2 Monoclonal Antibody, in Randomized, Phase I Clinical Studies. Clin Transl Sci. 2025 Oct;18(10):e70338. doi: 10.1111/cts.70338.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 282 in people with Chronic Rhinosinusitis With Nasal Polyps, run by Amgen at 4 sites in United States.
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 3 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 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (time frame: 169 days). The study lists 2 primary outcomes in all. 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 NCT02170337, which also lists 1 linked publication.
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 1 Jun 2016.