Alopecia AreataPhase 2NCT02018042
An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata
A Phase 2 study testing Abatacept in people with Alopecia Areata, run by Columbia University at 1 site in United States.
Trial summary
Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune" disease. In this disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 31 Jul 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Written Informed Consent Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel.
- Must be between 18 and 75 years of age.
- Must have a diagnosis of moderate to severe AA - defined as the presence of equal to or more than 30% and equal to or less than 95% total scalp hair loss at baseline as measured using the SALT score. In addition, a few patients with 100% scalp hair loss will be enrolled.
- Duration of hair loss must be at least 3 months.
- There may be no evidence of regrowth present at baseline.
- Subjects may be naïve to treatment or unresponsive to intralesional (IL) steroids or other treatments for AA.
Show all 13Show fewer
- Must be willing to avoid live vaccines while on the study medication, and within 3 months of its discontinuation.
- Women of childbearing potential (WOCBP) must use highly effective methods of birth control [for up to 12 weeks after the last dose of investigational product] to minimize the risk of pregnancy]. WOCBP must follow instructions for birth control for the entire duration of the study including a minimum of 90 days after dosing has been completed.
- (Acceptable methods of highly effective birth control include: Condom with spermicide, Diaphragm and spermicide, Cervical cap and spermicide)
- The use of intrauterine devices, (IUDs) shall be at the discretion of the investigator.
- Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
- Women must not be breastfeeding
- Sexually active fertile men must use highly effective birth control if their partners are WOCBP. Men that are sexually active with WOCBP must follow instructions for birth control for the entire duration of the study and a minimum of 90 days after dosing has been completed.
Who cannot join
- Sex and Reproductive Status
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
- WOCBP using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or before administration of abatacept.
- Sexually active fertile men not using effective birth control if their partners are WOCBP.
Show all 39Show fewer
- Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis.
- Patients in whom the diagnosis of alopecia areata is in question.
- Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.
- Patients with COPD
- Patients known to be HIV or hepatitis B or C positive.
- Patients with history or evidence of hematopoietic abnormality.
- Patients with history of immunosuppression or history of recurrent serious infections.
- Patients unwilling or unable to discontinue treatments known to affect hair regrowth in AA
- Coexisting disease or concurrent medications
- Patients taking TNF antagonists or other biological therapy such as anakinra.
- Patients with evidence of infection or active/untreated skin cancer.
- Patients who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, DPCP (diphenylcycloprophenone), protopic, minoxidil or other medication which in the opinion of the investigator may affect hair regrowth within one month of the baseline visit.
- Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
- Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Female subjects who have had a breast cancer screening that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded by additional clinical, laboratory, or other diagnostic evaluations.
- Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cancers cured by local resection or carcinoma in situ. Existing non-melanoma skin cancers should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug.
- Subjects who currently abuse drugs or alcohol.
- Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of human immunodeficiency virus (HIV) detected during screening.
- Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed.
- Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication.
- Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis).
- Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be subjects with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
- Subjects known to be positive for HIV, hepatitis B or C.
- Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
- Subjects with any of the following laboratory values Hemoglobin < 10.0 g/dL WBC < 3500/mm3 (< 3 x 109/L) Platelets < 120,000/mm3 (< 3 x 109/L) Serum creatinine > 2 times the ULN Serum ALT or AST > 2 times the ULN
- Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- PROHIBITED TREATMENTS AND/OR THERAPIES:
- Subjects who have at any time received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose.
- Any concomitant biologic DMARD, such as anakinra.
- Subjects who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, DPCP (diphenylcycloprophenone), protopic, minoxidil or other medication which in the opinion of the investigator may affect hair regrowth within one month of the baseline visit.
- OTHER EXCLUSION CRITERIA
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center - Department of Dermatology
New York, New York, 10032
About this study
Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune" disease. In this disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat Alopecia Areata has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for Alopecia Areata.
Abatacept (made by Bristol-Myers Squibb) is a safe intervention known to effectively treat rheumatoid arthritis, another "autoimmune" disease, by fighting inflammation. There are some genetic and chemical similarities between those with active rheumatoid arthritis and Alopecia Areata, suggesting that treatment with the same drug is likely to be effective. In mice specially designed for testing drugs for the treatment of human alopecia, this medication worked to prevent the disease Alopecia Areata from starting.
Read more
To test Abatacept, we are going to treat 15 patients with moderate to severe Alopecia Areata for 6 months. Each person enrolling into this study will receive the active study drug. The effectiveness of the medication will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician scoring. Patients will be followed for another 6 months off of the drug to see if the effects of treatment last and if there is delayed response. We have recently changed the study to allow testing of abatacept in a few patients with alopecia totalis and universalis.
Small scalp biopsies and peripheral blood will be taken at the beginning of the study before treatment and then after 4,12 and 24 weeks. The chemical analysis of these skin samples and blood will help us to understand how the disease happens, how the treatment works, and perhaps even guide us to better treatments in the future.
Read the detailed description
Among patients with alopecia areata, patients with higher disease burdens are unlikely to have satisfactory outcomes with current therapies. Our hypothesis is that CTLA4-Ig will be effective therapy in moderate-severe alopecia areata by blocking re-activation of CD8+ memory T cells, thereby aborting the cytotoxic T cell inflammatory response underlying alopecia areata.
Alopecia areata (AA) is a common autoimmune disease resulting from immune destruction of the hair follicle and subsequent hair loss. Despite its high prevalence, research into the pathogenesis and the development of innovative therapies in Alopecia Areata has lagged far behind other autoimmune diseases. Currently, there are no FDA approved drugs for Alopecia Areata. Abatacept is a safe intervention known to block costimulation and inflammatory responses in rheumatoid arthritis, which shares several susceptibility genes in common with Alopecia Areata. Both diseases share the involvement of CTLA4, which is the rationale for selecting Abatacept for evaluation in this clinical trial. CTLA4-Ig has been shown to prevent the onset of Alopecia Areata in the C3H-HeJ animal model of Alopecia Areata, demonstrating preclinical proof of concept data in Alopecia Areata.
We will conduct an open label pilot study of 15 patients with moderate to severe Alopecia Areata treated with SC abatacept 125mg once per week for 6 months. A few subjects with alopecia totalis or universalis will also be included. Subjects will be followed for another 6 months to evaluate durability of response following the treatment phase. The primary efficacy outcome will be the proportion of responders after 6 months of treatment compared to the historically known rate of response in untreated/placebo-treated subjects of 8 to 10%. Punch biopsies and peripheral blood will be obtained at baseline prior to treatment and then after 4, 12 and 24 weeks for immunomonitoring and molecular studies.
The safety of and incidence of adverse events related to abatacept in this population of patients will also be analyzed as a secondary endpoint.
- Conditions
- Alopecia Areata
- Being tested
- Abatacept
- Keywords
- Alopecia Areata, AA
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
After the screening period, subjects will begin weekly self-administered subcutaneous abatacept and will continue treatment for 6 months. Patients will be instructed in self-administration of study medication at baseline (week zero) and will be observed self-administering medication at each visit. Instructions regarding study drug administration will be reinforced as needed.
The 6-month treatment period is expected to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with moderate to severe AAP. Responders will then be followed for 6 months off drug.
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | Patients will be treated with abatacept 125mg subcutaneous (SC) self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse. Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Participants With At Least 50% Hair Regrowth
The study's primary efficacy endpoint will be the proportion of responders after 6 months of treatment, with response defined as 50% or greater hair re-growth from baseline as assessed by Severity of Alopecia Tool (SALT) score at week 24. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize the potential for spontaneous remission, in which fewer than 10% are expected to achieve this magnitude of hair regrowth spontaneously.
Measured: Week 24
Secondary outcomes (2)
Percentage of Hair Regrowth
Percent hair regrowth from baseline determined by global overall improvement in SALT measurements following 24 weeks of treatment.
Measured: Week 24
Measurement of Quality of Life
Quality of life measures were based on changes in the Dermatology Life Quality Index (DLQI). The DLQi is a 10-item questionnaire with each question scored from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0 (better outcome). The higher the score, the more quality of life is impaired.
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startSep 2013
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
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 Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Julian Mackay-Wiggan, MD, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018042
- Sponsor's protocol ID
- AAAK2167
- Status last verified
- Apr 2019
- First submitted
- 17 Dec 2013
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Biran R, Zlotogorski A, Ramot Y. The genetics of alopecia areata: new approaches, new findings, new treatments. J Dermatol Sci. 2015 Apr;78(1):11-20. doi: 10.1016/j.jdermsci.2015.01.004. Epub 2015 Jan 28.
PubMed 25676427
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata
- ClinicalTrials.gov ID
- NCT02018042
- Acronym / sponsor ID
- AAAK2167
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, AA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2013
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Posted 17 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune" disease. In this disease, the immune system mistakenly destroys the hair follicle, causing hair to fall out. Despite many people having this disease, research into its cause and into new, better ways to treat Alopecia Areata has lagged far behind other similar diseases of the immune system. Currently, there are no Federal Drug Administration approved drugs for Alopecia Areata.
Abatacept (made by Bristol-Myers Squibb) is a safe intervention known to effectively treat rheumatoid arthritis, another "autoimmune" disease, by fighting inflammation. There are some genetic and chemical similarities between those with active rheumatoid arthritis and Alopecia Areata, suggesting that treatment with the same drug is likely to be effective. In mice specially designed for testing drugs for the treatment of human alopecia, this medication worked to prevent the disease Alopecia Areata from starting.
To test Abatacept, we are going to treat 15 patients with moderate to severe Alopecia Areata for 6 months. Each person enrolling into this study will receive the active study drug. The effectiveness of the medication will be measured by changes in hair re-growth as determined by physical exam and photography, as well as by patient and physician scoring. Patients will be followed for another 6 months off of the drug to see if the effects of treatment last and if there is delayed response. We have recently changed the study to allow testing of abatacept in a few patients with alopecia totalis and universalis.
Small scalp biopsies and peripheral blood will be taken at the beginning of the study before treatment and then after 4,12 and 24 weeks. The chemical analysis of these skin samples and blood will help us to understand how the disease happens, how the treatment works, and perhaps even guide us to better treatments in the future.
Detailed description
Among patients with alopecia areata, patients with higher disease burdens are unlikely to have satisfactory outcomes with current therapies. Our hypothesis is that CTLA4-Ig will be effective therapy in moderate-severe alopecia areata by blocking re-activation of CD8+ memory T cells, thereby aborting the cytotoxic T cell inflammatory response underlying alopecia areata.
Alopecia areata (AA) is a common autoimmune disease resulting from immune destruction of the hair follicle and subsequent hair loss. Despite its high prevalence, research into the pathogenesis and the development of innovative therapies in Alopecia Areata has lagged far behind other autoimmune diseases. Currently, there are no FDA approved drugs for Alopecia Areata. Abatacept is a safe intervention known to block costimulation and inflammatory responses in rheumatoid arthritis, which shares several susceptibility genes in common with Alopecia Areata. Both diseases share the involvement of CTLA4, which is the rationale for selecting Abatacept for evaluation in this clinical trial. CTLA4-Ig has been shown to prevent the onset of Alopecia Areata in the C3H-HeJ animal model of Alopecia Areata, demonstrating preclinical proof of concept data in Alopecia Areata.
We will conduct an open label pilot study of 15 patients with moderate to severe Alopecia Areata treated with SC abatacept 125mg once per week for 6 months. A few subjects with alopecia totalis or universalis will also be included. Subjects will be followed for another 6 months to evaluate durability of response following the treatment phase. The primary efficacy outcome will be the proportion of responders after 6 months of treatment compared to the historically known rate of response in untreated/placebo-treated subjects of 8 to 10%. Punch biopsies and peripheral blood will be obtained at baseline prior to treatment and then after 4, 12 and 24 weeks for immunomonitoring and molecular studies.
The safety of and incidence of adverse events related to abatacept in this population of patients will also be analyzed as a secondary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Drug: AbataceptPatients will be treated with abatacept 125mg subcutaneous (SC) self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Written Informed Consent Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel.
- Must be between 18 and 75 years of age.
- Must have a diagnosis of moderate to severe AA - defined as the presence of equal to or more than 30% and equal to or less than 95% total scalp hair loss at baseline as measured using the SALT score. In addition, a few patients with 100% scalp hair loss will be enrolled.
- Duration of hair loss must be at least 3 months.
- There may be no evidence of regrowth present at baseline.
Key exclusion criteria (39 listed)
- Sex and Reproductive Status
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
- WOCBP using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or before administration of abatacept.
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 |
|---|---|---|
| AbataceptAlso: OrenciaAfter the screening period, subjects will begin weekly self-administered subcutaneous abatacept and will continue treatment for 6 months. Patients will be instructed in self-administration of study medication at baseline (week zero) and will be observed self-administering medication at each visit. Instructions regarding study drug administration will be reinforced as needed. The 6-month treatment period is expected to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with moderate to severe AAP. Responders will then be followed for 6 months off drug. | Drug | Abatacept |
Primary outcome
Total Number of Participants With At Least 50% Hair Regrowth
Time frame: Week 24
The study's primary efficacy endpoint will be the proportion of responders after 6 months of treatment, with response defined as 50% or greater hair re-growth from baseline as assessed by Severity of Alopecia Tool (SALT) score at week 24. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize the potential for spontaneous remission, in which fewer than 10% are expected to achieve this magnitude of hair regrowth spontaneously.
2 secondary outcomes
Percentage of Hair Regrowth
Time frame: Week 24
Measurement of Quality of Life
Time frame: Baseline, Week 12, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25676427Biran R, Zlotogorski A, Ramot Y. The genetics of alopecia areata: new approaches, new findings, new treatments. J Dermatol Sci. 2015 Apr;78(1):11-20. doi: 10.1016/j.jdermsci.2015.01.004. Epub 2015 Jan 28.
- 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.
Julian Mackay-Wiggan, MD, MS principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abatacept in people with Alopecia Areata, run by Columbia University at 1 site 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 13 inclusion and 39 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 17 Apr 2019). 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?
Total Number of Participants With At Least 50% Hair Regrowth (time frame: Week 24). 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 NCT02018042, 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 30 Apr 2019.