Healthy VolunteersPhase 1NCT03969849
Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants
A Phase 1 study testing REGN5713-5714-5715 in people with Healthy Volunteers and Birch Pollen Allergy, run by Regeneron Pharmaceuticals at 3 sites in Belgium.
Trial summary
The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants. The secondary objectives of the study are: In Part A and Part B: To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults To assess the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Birch Pollen Allergy
- What is being tested?
- REGN5713-5714-5715
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 3 sitesBelgium
- Study dates
- 3 Jun 2019to 27 Mar 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed prior to study drug dosing
- Participant is in good health based on laboratory safety testing obtained at the screening prior to study drug dosing
- Part B: Has a medical history of birch tree pollen-triggered allergic rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons) based on participant's recall
- Part B: Has positive skin prick test (SPT) with birch tree pollen extract (mean wheal diameter ≥5 mm greater than a negative control) in screening period
Who cannot join
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confound the results of the study or pose an additional risk to the participant by study participation
- Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by study participation
- Participation in any clinical research study evaluating another investigational drug or therapy within 90 days or at least 5 half-lives (whichever is longer) for an investigational biologic drug, or at least 28 days for other investigational products, or within 6 months for immunotherapy prior to the screening visit of the current trial
- Pregnant or breastfeeding women
- Part B: Receipt of study drug REGN5713-5714-5715 in Part A
- Part B: Significant rhinitis or sinusitis outside of the birch pollen season or due to daily contact with other allergens causing symptoms, that is expected to coincide with the study NAC assessments as assessed by the investigator
Show all 9Show fewer
- Part B: A clinical history of asthma requiring chronic medication such as regular, inhaled corticosteroids for >6 months per year
- Part B: History of birch allergy immunotherapy (SCIT, sublingual immunotherapy, or oral immunotherapy) in the 5 years prior to screening
- NOTE: Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Regeneron Study Site
Antwerp
Regeneron Study Site
Ghent
Regeneron Study Site
Leuven
About this study
Official title: A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Subjects
The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants.
The secondary objectives of the study are:
Read more
In Part A and Part B:
- To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults
- To assess the immunogenicity of single dose of REGN5713-5714-5715.
In Part B:
- To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715
- To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.
- Conditions
- Healthy Volunteers, Birch Pollen Allergy
- Being tested
- REGN5713-5714-5715, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5713-5714-5715Drug
Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
Matching placeboDrug
Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1 | Experimental | Part A: Cohort 1 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo Receives: Drug: REGN5713-5714-5715; Drug: Matching placebo |
| Part A: Cohort 2 | Experimental | Part A: Cohort 2 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo Receives: Drug: REGN5713-5714-5715; Drug: Matching placebo |
| Part A: Cohort 3 | Experimental | Part A: Cohort 3 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo Receives: Drug: REGN5713-5714-5715; Drug: Matching placebo |
| Part A: Cohort 4 | Experimental | Part A: Cohort 4 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo Receives: Drug: REGN5713-5714-5715; Drug: Matching placebo |
| Part B | Experimental | Part B: Randomized 1:1 will receive REGN5713-5714-5715 or matching placebo in Healthy Participants with birch pollen allergy Receives: Drug: REGN5713-5714-5715; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Up to 16 Weeks
The number of participants with abnormal adverse events (AEs)
Measured: Up to 16 Weeks
The number of participants with abnormal vital signs
Vital signs include blood pressure, heart rate, body temperature, and respiratory rate
Measured: Up to 16 Weeks
The number of participants with abnormal 12-lead electrocardiograms (ECGs)
Measured: Up to 16 Weeks
The number or participants with abnormal physical examinations
The limited physical examination will include assessment of heart, lungs, abdomen, peripheral pulses, and skin
Measured: Up to 16 Weeks
The number of abnormal laboratory examination
Hematology, chemistry, urinalysis and pregnancy testing samples will be analyzed
Measured: Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - forced vital capacity (FVC) litres (L)
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FVC is the total amount of air exhaled during the forced expiratory volume (FEV) test
Measured: Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory volume in 1 second (FEV1)
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV in 1 second (FEV1) must be ≥80% predicted to perform the NAC. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
Measured: Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - FEV1/FVC (%)
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV1 must be ≥80% predicted to perform the NAC.
Measured: Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - peak expiratory flow (PEF) Litre/second (L/s)
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. PEF is the maximum speed of expiration.
Measured: Up to 16 Weeks
Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory flow 25 to 75 (L/s)
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. Forced expiratory flow during the mid (25 - 75%) portion of the FVC.
Measured: Up to 16 Weeks
Part B only - The number of participants with poorly controlled asthma using asthma control test (ACT)
Performed prior to every NAC procedure in all participants. A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control. Participants must have ACT ≥20 before undergoing the NAC.
Measured: Up to 16 Weeks
Secondary outcomes (10)
Total concentration of REGN5713 in serum over time
Measured: Up to 16 Weeks
Total concentration of REGN5714 in serum over time
Measured: Up to 16 Weeks
Total concentration of REGN5715 in serum over time
Measured: Up to 16 Weeks
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN5713
Measured: Up to 16 Weeks
Immunogenicity as measured by ADA to REGN5714
Measured: Up to 16 Weeks
Immunogenicity as measured by ADA to REGN5715
Measured: Up to 16 Weeks
Change in area under the curve (AUC) for TNSS (0 to 1 hour post-peak TNSS) in response to a nasal allergen challenge (NAC) from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo
Measured: At day 8, 29 and 57
Percent change in AUC for TNSS (0 to 1 hour post-peak TNSS) in response to a NAC from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo
Measured: At day 8, 29 and 57
Change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo
Measured: At day 8, 29 and 57
Percent change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo
Measured: At day 8, 29 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start3 Jun 2019
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969849
- Sponsor's protocol ID
- R5713-5714-5715-HV-1857
- Other IDs
- 2018-004681-34, 2018
- Status last verified
- Apr 2020
- First submitted
- 28 May 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie publicly available results will be considered for sharing
Publications
Gevaert P, De Craemer J, De Ruyck N, Rottey S, de Hoon J, Hellings PW, Volckaert B, Lesneuck K, Orengo JM, Atanasio A, Kamal MA, Abdallah H, Kamat V, Dingman R, DeVeaux M, Ramesh D, Perlee L, Wang CQ, Weinreich DM, Herman G, Yancopoulos GD, O'Brien MP. Novel antibody cocktail targeting Bet v 1 rapidly and sustainably treats birch allergy symptoms in a phase 1 study. J Allergy Clin Immunol. 2022 Jan;149(1):189-199. doi: 10.1016/j.jaci.2021.05.039. Epub 2021 Jun 11.
PubMed 34126156
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03969849
- Acronym / sponsor ID
- R5713-5714-5715-HV-1857
- Conditions
- Healthy Volunteers, Birch Pollen Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 31 May 2019 (actual)
- 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.
The primary objective of the study is to evaluate the safety and tolerability of REGN5713-5714-5715 in healthy adult participants.
The secondary objectives of the study are:
In Part A and Part B:
- To characterize the concentration time profile of single doses of REGN5713-5714-5715 in healthy adults
- To assess the immunogenicity of single dose of REGN5713-5714-5715.
In Part B:
- To assess the inhibition of allergic symptoms as measured by total nasal symptom score (TNSS) provoked by a birch allergen nasal allergen challenge (NAC) in birch-sensitized allergic subjects after a single subcutaneous (SC) dose of REGN5713-5714-5715
- To assess the skin test reactivity provoked by a skin prick test (SPT) with serial birch allergen titration after a single SC dose of REGN5713-5714-5715.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1 | Experimental | Drug: REGN5713-5714-5715, Drug: Matching placeboPart A: Cohort 1 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part A: Cohort 2 | Experimental | Drug: REGN5713-5714-5715, Drug: Matching placeboPart A: Cohort 2 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part A: Cohort 3 | Experimental | Drug: REGN5713-5714-5715, Drug: Matching placeboPart A: Cohort 3 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part A: Cohort 4 | Experimental | Drug: REGN5713-5714-5715, Drug: Matching placeboPart A: Cohort 4 randomized 3:1 will receive REGN5713-5714-5715 or matching placebo |
| Part B | Experimental | Drug: REGN5713-5714-5715, Drug: Matching placeboPart B: Randomized 1:1 will receive REGN5713-5714-5715 or matching placebo in Healthy Participants with birch pollen allergy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed prior to study drug dosing
- Participant is in good health based on laboratory safety testing obtained at the screening prior to study drug dosing
- Part B: Has a medical history of birch tree pollen-triggered allergic rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons) based on participant's recall
- Part B: Has positive skin prick test (SPT) with birch tree pollen extract (mean wheal diameter ≥5 mm greater than a negative control) in screening period
Key exclusion criteria (9 listed)
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confound the results of the study or pose an additional risk to the participant by study participation
- Has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by study participation
- Participation in any clinical research study evaluating another investigational drug or therapy within 90 days or at least 5 half-lives (whichever is longer) for an investigational biologic drug, or at least 28 days for other investigational products, or within 6 months for immunotherapy prior to the screening visit of the current trial
- Pregnant or breastfeeding women
- Part B: Receipt of study drug REGN5713-5714-5715 in Part A
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 |
|---|---|---|
| REGN5713-5714-5715Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose | Drug | Part A: Cohort 1, Part A: Cohort 2, Part A: Cohort 3, Part A: Cohort 4, Part B |
| Matching placeboPart A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose | Drug | Part A: Cohort 1, Part A: Cohort 2, Part A: Cohort 3, Part A: Cohort 4, Part B |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 16 Weeks
The number of participants with abnormal adverse events (AEs)
Time frame: Up to 16 Weeks
The number of participants with abnormal vital signs
Time frame: Up to 16 Weeks
Vital signs include blood pressure, heart rate, body temperature, and respiratory rate
The number of participants with abnormal 12-lead electrocardiograms (ECGs)
Time frame: Up to 16 Weeks
The number or participants with abnormal physical examinations
Time frame: Up to 16 Weeks
The limited physical examination will include assessment of heart, lungs, abdomen, peripheral pulses, and skin
The number of abnormal laboratory examination
Time frame: Up to 16 Weeks
Hematology, chemistry, urinalysis and pregnancy testing samples will be analyzed
Part B only - The number of participants with abnormal lung function using spirometry - forced vital capacity (FVC) litres (L)
Time frame: Up to 16 Weeks
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FVC is the total amount of air exhaled during the forced expiratory volume (FEV) test
Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory volume in 1 second (FEV1)
Time frame: Up to 16 Weeks
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV in 1 second (FEV1) must be ≥80% predicted to perform the NAC. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
Part B only - The number of participants with abnormal lung function using spirometry - FEV1/FVC (%)
Time frame: Up to 16 Weeks
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. FEV1 must be ≥80% predicted to perform the NAC.
Part B only - The number of participants with abnormal lung function using spirometry - peak expiratory flow (PEF) Litre/second (L/s)
Time frame: Up to 16 Weeks
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. PEF is the maximum speed of expiration.
Part B only - The number of participants with abnormal lung function using spirometry - forced expiratory flow 25 to 75 (L/s)
Time frame: Up to 16 Weeks
Spirometry will be measured only in participants with a history of asthma prior to the NAC procedure. Forced expiratory flow during the mid (25 - 75%) portion of the FVC.
Part B only - The number of participants with poorly controlled asthma using asthma control test (ACT)
Time frame: Up to 16 Weeks
Performed prior to every NAC procedure in all participants. A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control. Participants must have ACT ≥20 before undergoing the NAC.
10 secondary outcomes
Total concentration of REGN5713 in serum over time
Time frame: Up to 16 Weeks
Total concentration of REGN5714 in serum over time
Time frame: Up to 16 Weeks
Total concentration of REGN5715 in serum over time
Time frame: Up to 16 Weeks
Immunogenicity as measured by anti-drug antibodies (ADA) to REGN5713
Time frame: Up to 16 Weeks
Immunogenicity as measured by ADA to REGN5714
Time frame: Up to 16 Weeks
Immunogenicity as measured by ADA to REGN5715
Time frame: Up to 16 Weeks
Change in area under the curve (AUC) for TNSS (0 to 1 hour post-peak TNSS) in response to a nasal allergen challenge (NAC) from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo
Time frame: At day 8, 29 and 57
Percent change in AUC for TNSS (0 to 1 hour post-peak TNSS) in response to a NAC from the pretreatment baseline TNSS AUC (0 to 1 hour post-peak TNSS) for REGN5713-5714-5715 as compared to placebo
Time frame: At day 8, 29 and 57
Change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo
Time frame: At day 8, 29 and 57
Percent change in mean wheal diameters of the skin prick test with serial birch allergen titration from the pretreatment baseline for REGN5713-5714-5715 as compared to placebo
Time frame: At day 8, 29 and 57
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 28 Apr 2020.
- Derived from this study: PubMed 34126156Gevaert P, De Craemer J, De Ruyck N, Rottey S, de Hoon J, Hellings PW, Volckaert B, Lesneuck K, Orengo JM, Atanasio A, Kamal MA, Abdallah H, Kamat V, Dingman R, DeVeaux M, Ramesh D, Perlee L, Wang CQ, Weinreich DM, Herman G, Yancopoulos GD, O'Brien MP. Novel antibody cocktail targeting Bet v 1 rapidly and sustainably treats birch allergy symptoms in a phase 1 study. J Allergy Clin Immunol. 2022 Jan;149(1):189-199. doi: 10.1016/j.jaci.2021.05.039. Epub 2021 Jun 11.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie publicly available results will be considered for sharing
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
3 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 REGN5713-5714-5715 in people with Healthy Volunteers and Birch Pollen Allergy, run by Regeneron Pharmaceuticals at 3 sites in Belgium.
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 9 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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. 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?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Up to 16 Weeks). The study lists 12 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 NCT03969849, 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 28 Apr 2020.