Peanut AllergyPhase 2NCT02920021

Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut Allergy

A Phase 2 study testing Etokimab in people with Peanut Allergy, run by AnaptysBio, Inc. at 2 sites in United States.

Completed

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

Trial summary

The purpose of this study is to determine etokimab safety, tolerability and activity in adult participants with peanut allergy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peanut Allergy
What is being tested?: Etokimab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 26 Jan 2017to 30 Mar 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female participants with age > 18 years and able to give informed consent.
Participants with a confirmed clinically allergic response to peanut.
Positive clinical reaction during the peanut oral food challenge and no clinical reaction during the placebo challenge
Positive peanut allergy skin prick test > 3 millimeters (mm) of the negative control and detectable serum peanut-specific Immunoglobulin E (IgE) levels by ImmunoCAP testing.
Body mass index (BMI) of 18 to 36 kilogram per square meter (kg/m^2) inclusive) and total body weight > 50 kg (110 lb). BMI = weight (kg)/(height [m^2]).
Willing and able to comply with the study protocol requirements.

Show all 9Show fewer

Have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the Investigator and staff.
Women of childbearing potential, must have a negative serum pregnancy test at screening and Day 1, and be surgically sterile or using an acceptable method of contraception throughout the study and for 15 weeks after the last administration of investigational product. Postmenopausal participants defined as (1) aged over 45 years with at least 1 year of amenorrhea and levels of follicle stimulating hormone over 20 international units per liter (IU/L) or (2) aged over 50 years with at least 1 year of amenorrhea.
Male participants must be willing to use effective methods of contraception during the entire study period and for 15 weeks after the last administration of investigational product.

Who cannot join

Have concomitant dermatological or medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product.
Have experienced severe life-threatening anaphylactic reactions to peanuts within 6 months before screening (i.e., requiring an intensive care unit [ICU] admission).
Positive clinical reaction observed during the placebo oral food challenge.
Participation in any interventional study for the treatment of peanut and/or food allergies in the 12 months before screening.
Have received any investigational product or been part of any interventional clinical study within a period of 3 months or 5 half-lives (whichever is longer) before screening.
Have received systemic corticosteroids, nonsteroidal, immunosuppressant, or immunomodulating drugs treatments within 2 weeks before screening.

Show all 20Show fewer

Use of beta blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers within 2 weeks before screening.
History of ischemic cardiovascular diseases.
Use of biologics within 6 months before screening or participant is in build-up phase of allergen immunotherapy (excluding peanut) and has not reached maintenance dose.
Have received antibiotic treatment within 1 week before screening.
Have a history of hypersensitivity or allergic reactions following infusions of human blood or blood components.
Have a history of hypersensitivity or allergic reactions a component of etokimab formulation or the inactive ingredients (excipients).
If female, are pregnant or lactating, or intend to become pregnant during the study period.
Current diagnosis of asthma requiring Global Initiative for Asthma Assessment (GINA) Step 4 or higher treatment or asthma partially controlled or uncontrolled according to GINA classifications in the last three months before screening.
History of a life threatening asthma attack within 1 year before screening (example: requiring an intensive care unit admission, intubation with mechanical ventilation).
Other significant medical conditions that in the opinion of the Principal Investigator, prevent participation in the study.
History of drug, alcohol or other substance abuse, or other factors limiting the ability to cooperate and to comply with the study protocol.
Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments.
Receipt of a live attenuated vaccine within 4 weeks before screening.
Planned surgery during the study or 30 days before screening.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Stanford Univ. Medical Center
Palo Alto, California, 94305
Asthma, Inc Clinical Research Center
Seattle, Washington, 98115

Other trials in United States

About this study

Official title: Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy

The purpose of this study is to determine etokimab safety, tolerability and activity in adult participants with peanut allergy.

Read the detailed description

This is a multi-center, randomized, double-blind, placebo-controlled, proof of concept study to assess the safety and tolerability of etokimab in adult participants with peanut allergy.

Conditions: Peanut Allergy
Being tested: Etokimab, Placebo
Medical subject headings: Peanut Hypersensitivity

What participants receive

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

EtokimabDrug
Also called ANB020
Humanized monoclonal antibody, administered by intravenous infusion
PlaceboDrug
Administered by intravenous infusion

Study groups in NCT02920021
Study group	Role	What they receive
Etokimab	Experimental	Participants received a single dose of 300 milligrams (mg) etokimab administered by 1-hour intravenous (IV) infusion on Day 1. Receives: Drug: Etokimab
Placebo	Placebo comparator	Participants received a single dose of placebo administered by 1-hour IV infusion on Day 1. Receives: Drug: Placebo

What is being measured

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

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AEs include any clinical laboratory test results determined to be clinically significant by the investigator. AE was considered "serious" if there was any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Each AE was evaluated for severity (mild, moderate, or severe) and causal relationship to the study drug. AE was considered TEAE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Measured: From first dose of study drug up to 45 days.
Change From Baseline in Cumulative Tolerated Peanut Dose During Oral Food Challenge
Oral food challenges were performed at Baseline and Day 14 in accordance with the Practical Allergy (PRACTALL) consensus report. Escalating doses of peanut protein (peanut flour mixed with a non-allergic food vehicle such as apple sauce) consisting of 5, 20, 50, 100, 100, 100, and 125 mg (for a cumulative maximum dose of 500 mg) were given at 20 minute intervals. If the participant developed any signs of an objective allergic reaction, the challenge was stopped. The total cumulative tolerated dose of blinded peanut reached prior to reaction was recorded.
Measured: Baseline and Day 14

Secondary outcomes (10)

Change From Baseline in Oral Food Challenge Symptom Score at Day 14
Oral food challenges were performed at Baseline and Day 14 in accordance with the PRACTALL consensus report.
During OFC the OFC Symptom Scoring Assessment Tool was used to assess participants for common symptoms that can be suspected to be an allergic reaction involving the skin, upper respiratory, lower respiratory, gastrointestinal, and cardiovascular systems. Each symptom was scored according to the following scale: Grade 0 = sign or symptom not observed; Grade 1 = mild; Grade 2 = moderate, Grade 3 = severe. The score from each symptom was averaged to calculate the overall score at Baseline and on Day 14.
Measured: Baseline and Day 14
Maximum Observed Concentration (Cmax) of Etokimab
The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 microgram per milliliter (μg/mL).
Measured: Day 1 predose, 0.5 hours after the start of the infusion, end of infusion (EOI), 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Time to Maximum Observed Concentration (Tmax) of Etokimab
The concentration of etokimab was measured using a validated assay method. The lower limit of quantification (LLOQ) was 0.400 μg/mL.
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Area Under the Concentration-time Curve in Serum From Time Zero Extrapolated to Infinite Time (AUC0-inf) for Etokimab
Area under the concentration-time curve in serum from time zero (predose) extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration (Clast) divided by the apparent terminal rate constant (λz): AUC(0-last) + Clast/λz.
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Area Under the Concentration-time Curve in Serum From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) for Etokimb
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration, calculated by linear up/log down trapezoidal summation.
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Apparent Terminal Half-life (T1/2) for Etokimab
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Systemic Clearance for Etokimab
Systemic clearance calculated as dose/ AUC(0-inf).
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Volume of Distribution at Steady State Following IV Dosing (Vss) for Etokimab
Volume of distribution at steady state following intravenous dosing, calculated as mean residence time (extrapolated to infinity) multiplied by systemic clearance.
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Volume of Distribution (Vz)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Volume of distribution was estimated by dividing the systemic clearance by apparent terminal rate constant (λz).
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Apparent Terminal Rate Constant (λz)
The terminal elimination rate constant (λz) is defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase. Apparent terminal rate constant was determined by linear regression of the terminal points of the log-linear concentration-time curve.
Measured: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.

Timeline

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

26 Jan 201730 Mar 2018

First posted30 Sep 2016 (estimated)
Study start26 Jan 2017
Primary completion30 Mar 2018
Study completion30 Mar 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peanut AllergyStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02920021
Sponsor's protocol ID: ANB020-003
Status last verified: Jul 2023
First submitted: 26 Sep 2016
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Chinthrajah S, Cao S, Liu C, Lyu SC, Sindher SB, Long A, Sampath V, Petroni D, Londei M, Nadeau KC. Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy. JCI Insight. 2019 Nov 14;4(22):e131347. doi: 10.1172/jci.insight.131347.
PubMed 31723064

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

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All Peanut Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Peanut Allergy
ClinicalTrials.gov ID: NCT02920021
Acronym / sponsor ID: ANB020-003
Conditions: Peanut Allergy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: AnaptysBio, Inc.Industry (pharma, biotech, devices)
Study start: 26 Jan 2017 (actual)
Primary completion: 30 Mar 2018 (actual)
Study completion: 30 Mar 2018 (actual)
First posted: 30 Sep 2016 (estimated)
Results: Posted 27 Jul 2023

Clinical summary

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

The purpose of this study is to determine etokimab safety, tolerability and activity in adult participants with peanut allergy.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled, proof of concept study to assess the safety and tolerability of etokimab in adult participants with peanut allergy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Etokimab	Experimental	Drug: EtokimabParticipants received a single dose of 300 milligrams (mg) etokimab administered by 1-hour intravenous (IV) infusion on Day 1.
Placebo	Placebo comparator	Drug: PlaceboParticipants received a single dose of placebo administered by 1-hour IV infusion on Day 1.

Who may qualify

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

Key inclusion criteria (9 listed)

Male and female participants with age > 18 years and able to give informed consent.
Participants with a confirmed clinically allergic response to peanut.
Positive clinical reaction during the peanut oral food challenge and no clinical reaction during the placebo challenge
Positive peanut allergy skin prick test > 3 millimeters (mm) of the negative control and detectable serum peanut-specific Immunoglobulin E (IgE) levels by ImmunoCAP testing.
Body mass index (BMI) of 18 to 36 kilogram per square meter (kg/m^2) inclusive) and total body weight > 50 kg (110 lb). BMI = weight (kg)/(height [m^2]).

Key exclusion criteria (20 listed)

Have concomitant dermatological or medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product.
Have experienced severe life-threatening anaphylactic reactions to peanuts within 6 months before screening (i.e., requiring an intensive care unit [ICU] admission).
Positive clinical reaction observed during the placebo oral food challenge.
Participation in any interventional study for the treatment of peanut and/or food allergies in the 12 months before screening.
Have received any investigational product or been part of any interventional clinical study within a period of 3 months or 5 half-lives (whichever is longer) before screening.

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
EtokimabAlso: ANB020Humanized monoclonal antibody, administered by intravenous infusion	Drug	Etokimab
PlaceboAdministered by intravenous infusion	Drug	Placebo

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to 45 days.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AEs include any clinical laboratory test results determined to be clinically significant by the investigator. AE was considered "serious" if there was any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Each AE was evaluated for severity (mild, moderate, or severe) and causal relationship to the study drug. AE was considered TEAE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Change From Baseline in Cumulative Tolerated Peanut Dose During Oral Food Challenge
Time frame: Baseline and Day 14
Oral food challenges were performed at Baseline and Day 14 in accordance with the Practical Allergy (PRACTALL) consensus report. Escalating doses of peanut protein (peanut flour mixed with a non-allergic food vehicle such as apple sauce) consisting of 5, 20, 50, 100, 100, 100, and 125 mg (for a cumulative maximum dose of 500 mg) were given at 20 minute intervals. If the participant developed any signs of an objective allergic reaction, the challenge was stopped. The total cumulative tolerated dose of blinded peanut reached prior to reaction was recorded.

10 secondary outcomes

Change From Baseline in Oral Food Challenge Symptom Score at Day 14
Time frame: Baseline and Day 14
Maximum Observed Concentration (Cmax) of Etokimab
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, end of infusion (EOI), 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Time to Maximum Observed Concentration (Tmax) of Etokimab
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Area Under the Concentration-time Curve in Serum From Time Zero Extrapolated to Infinite Time (AUC0-inf) for Etokimab
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Area Under the Concentration-time Curve in Serum From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) for Etokimb
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Apparent Terminal Half-life (T1/2) for Etokimab
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Systemic Clearance for Etokimab
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Volume of Distribution at Steady State Following IV Dosing (Vss) for Etokimab
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Volume of Distribution (Vz)
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.
Apparent Terminal Rate Constant (λz)
Time frame: Day 1 predose, 0.5 hours after the start of the infusion, EOI, 3 hours after EOI, 24, 96, 336 (Day 15), and 1056 (Day 45) hours after the start of infusion.

Results and safety

Results posted to the registry on 27 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etokimab	15	15
Placebo	5	5

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: From first dose of study drug up to 45 days.. Count of participants. Unit: Participants

Measure	Etokimab n = 15	Placebo n = 5
Any treatment-emergent adverse event (TEAE)	15	5
Serious TEAE	0	0
Mild TEAE	3	0
Moderate TEAE	9	5
Severe	3	0
TEAE related to study drug	1	0
Discontinued from the study due to TEAE	0	0

Population analysed: Safety Analysis Set included all participants who received any portion of etokimab or placebo infusion.

Primary outcome: Change From Baseline in Cumulative Tolerated Peanut Dose During Oral Food Challenge

Time frame: Baseline and Day 14. Least squares mean (Standard Error). Unit: mg

Measure	Etokimab n = 15	Placebo n = 5
Value	387.511 (39.053)	327.466 (68.692)

Etokimab vs Placebo: Least Squares (LS) Mean Difference: 60.046 (95% CI -108.566 to 228.657), p = 0.463, ANCOVA

Population analysed: Full Analysis Set (FAS) included all participants who received etokimab or placebo who were present in the study until Day 14 with post-baseline OFC results.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to Day 45. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etokimab	0 of 15 (0%)	15 of 15 (100%)	0 of 15
Placebo	0 of 5 (0%)	5 of 5 (100%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31723064Chinthrajah S, Cao S, Liu C, Lyu SC, Sindher SB, Long A, Sampath V, Petroni D, Londei M, Nadeau KC. Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy. JCI Insight. 2019 Nov 14;4(22):e131347. doi: 10.1172/jci.insight.131347.
Individual participant dataSharing planned: No

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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.

Bruce Randazzo, MD study director

AnaptysBio, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etokimab in people with Peanut Allergy, run by AnaptysBio, Inc. at 2 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 9 inclusion and 20 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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 27 Jul 2023). 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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From first dose of study drug up to 45 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 NCT02920021, 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 27 Jul 2023.