Dermatitis, Atopic DermatitisPhase 2NCT02087943

Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing Apremilast in people with Dermatitis, Atopic Dermatitis, run by Amgen at 31 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dermatitis, Atopic Dermatitis
What is being tested?: Apremilast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 191 participants
Where: 31 sitesin 3 countries
Study dates: Jun 2014to Feb 2016
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

Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.
Have a diagnosis of atopic dermatitis for ≥ 12 months.
Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.
Meet the laboratory criteria as defined per protocol
Females of Childbearing Potential (FCBP) must have a negative pregnancy test at Screening and Baseline. Sexually active FCBP must use one of the approved contraceptive options required per protocol while on and for at least 28 days after the last dose of study medication
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception while on and for at least 28 days after the last dose of study medication.

Who cannot join

Active tuberculosis (TB) or a history of inadequately treated tuberculosis.
Positive for hepatitis B surface antigen or hepatitis C antibody
Pregnant or breast feeding
History of allergy to any component of the study medication.
Active skin infection requiring systemic antimicrobials at Baseline.

Trial locations and contacts

31 sites in 3 countries.

Country

City, postcode or hospital

31 sites in 3 countries

United States15 sites

Emory Clinic
Atlanta, Georgia, 30322
Advanced Medical Research
Atlanta, Georgia, 30342
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309
Northwestern University Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Dermatology Research Associates
Los Angeles, California, 90045
Dermatology Specialists, PSC
Louisville, Kentucky, 40202
NYU Department of Dermatology
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Virginia Clinical Research Inc
Norfolk, Virginia, 23507
Renstar Medical Research
Ocala, Florida, 34471
Arizona Research Center
Phoenix, Arizona, 85023
Oregon Health and Science University
Portland, Oregon, 97201-3098
PMG Research of Winston-Salem LLC
Winston-Salem, North Carolina, 27103-3914

Other trials in United States

Japan10 sites

Kokubu Abashiri Dermatology Clinic
Abashiri-shi, Hokkaido, 093-0016
Asanuma Dermatology Clinic
Chitose-shi, Hokkaido, 066-0064
Fukuoka University Hospital Dermatology
Fukuoka-shi, Fukuoka, 814-0180
Hatamoto Dermatology Clinic
Fukuoka-shi, Fukuoka, 815-0075
Tashiro Clinic
Iizuka-shi, Fukuoka, 820-0040
Kokubu Dermatology
Kitami-shi, Hokkaido, 090-0832
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Kyoto University Hospital
Kyoto, 606-8507
Sapporo Skin Clinic
Sapporo-shi, Hokkaido, 060-0063
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625

Other trials in Japan

Canada6 sites

Ultranova Skincare
Barrie, Ontario, L4M 6L2
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, B3H 1Z2
Innovaderm Research
Montreal, Quebec, H2K 4L5
Centre Dermatologique du Quebec Metropolitain
Ste-Foy, Quebec, G1V 4X7
Chih-Ho Hong Medical, Inc.
Surrey, British Columbia, V3R 6A7
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4

Other trials in Canada

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Atopic Dermatitis

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

Conditions: Dermatitis, Atopic Dermatitis
Being tested: Apremilast, Placebo
Keywords: Atopic Dermatitis, Atopic Eczema
Medical subject headings: Dermatitis, Atopic

What participants receive

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

ApremilastDrug
Also called CC-10004, Otezla
Orally twice a day (BID)
ApremilastDrug
Also called CC-10004, Otezla
Orally twice a day (BID)
PlaceboDrug
Orally twice a day (BID)
PlaceboDrug
Orally twice a day (BID)

Study groups in NCT02087943
Study group	Role	What they receive
Apremilast 40 mg	Experimental	Apremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase Receives: Drug: Apremilast
Apremilast 30 mg	Experimental	Apremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase Receives: Drug: Apremilast
Placebo + Apremilast 40 mg	Experimental	Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase Receives: Drug: Apremilast; Drug: Placebo
Placebo + Apremilast 30 mg	Experimental	Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase Receives: Drug: Apremilast; Drug: Placebo
Placebo	Placebo comparator	Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase. Receives: Drug: Placebo

What is being measured

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

Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to Week 12

Secondary outcomes (5)

Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12.
The sPGA-A is intended to assess the global severities (ie, a "visual average" integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4).
Measured: Baseline to Week 12
Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12
The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.
Measured: Baseline to Week 12
The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4
The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline to Week 4
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.
Measured: Baseline to Week 12
Number of Participants With TEAEs During the Apremilast Exposure Period
A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.
Measured: Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg

Timeline

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

Jun 2014Feb 2016

First posted14 Mar 2014 (estimated)
Study startJun 2014
Primary completionOct 2015
Study completionFeb 2016

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 Dermatitis, Atopic DermatitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02087943
Sponsor's protocol ID: CC-10004-AD-001
Status last verified: Apr 2017
First submitted: 13 Mar 2014
Last updated: 7 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

Simpson EL, Imafuku S, Poulin Y, Ungar B, Zhou L, Malik K, Wen HC, Xu H, Estrada YD, Peng X, Chen M, Shah N, Suarez-Farinas M, Pavel AB, Nograles K, Guttman-Yassky E. A Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis. J Invest Dermatol. 2019 May;139(5):1063-1072. doi: 10.1016/j.jid.2018.10.043. Epub 2018 Dec 5.
PubMed 30528828

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 Dermatitis, Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT02087943
Acronym / sponsor ID: CC-10004-AD-001
Conditions: Dermatitis, Atopic Dermatitis
Keywords: Atopic Dermatitis, Atopic Eczema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Oct 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 14 Mar 2014 (estimated)
Results: Posted 12 Dec 2016

Clinical summary

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

A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Apremilast 40 mg	Experimental	Drug: ApremilastApremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase
Apremilast 30 mg	Experimental	Drug: ApremilastApremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase
Placebo + Apremilast 40 mg	Experimental	Drug: Apremilast, Drug: PlaceboPlacebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase
Placebo + Apremilast 30 mg	Experimental	Drug: Apremilast, Drug: PlaceboPlacebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase
Placebo	Placebo comparator	Drug: PlaceboOral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase.

Who may qualify

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

Key inclusion criteria (6 listed)

Males or females, aged ≥ 18 years (≥ 20 for Japanese subjects) at the time of consent.
Have a diagnosis of atopic dermatitis for ≥ 12 months.
Have moderate to severe atopic dermatitis which is considered inappropriate for topical therapy or which cannot be adequately controlled by topical therapy.
Meet the laboratory criteria as defined per protocol
Females of Childbearing Potential (FCBP) must have a negative pregnancy test at Screening and Baseline. Sexually active FCBP must use one of the approved contraceptive options required per protocol while on and for at least 28 days after the last dose of study medication

Key exclusion criteria (5 listed)

Active tuberculosis (TB) or a history of inadequately treated tuberculosis.
Positive for hepatitis B surface antigen or hepatitis C antibody
Pregnant or breast feeding
History of allergy to any component of the study medication.
Active skin infection requiring systemic antimicrobials at Baseline.

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
ApremilastAlso: CC-10004, OtezlaOrally twice a day (BID)	Drug	Apremilast 40 mg, Placebo + Apremilast 40 mg
ApremilastAlso: CC-10004, OtezlaOrally twice a day (BID)	Drug	Apremilast 30 mg, Placebo + Apremilast 30 mg
PlaceboOrally twice a day (BID)	Drug	Placebo + Apremilast 40 mg
PlaceboOrally twice a day (BID)	Drug	Placebo, Placebo + Apremilast 30 mg

Primary outcome

Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.
Time frame: Baseline to Week 12
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.

5 secondary outcomes

Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12.
Time frame: Baseline to Week 12
Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12
Time frame: Baseline to Week 12
The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4
Time frame: Baseline to Week 4
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period
Time frame: Baseline to Week 12
Number of Participants With TEAEs During the Apremilast Exposure Period
Time frame: Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg

Results and safety

Results posted to the registry on 12 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	64	50
Apremilast 30 mg	58	46
Apremilast 40 mg	63	50
Placebo/Apremilast 30 mg	0	0
Placebo/Apremilast 40 mg	0	0

Primary outcome: Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo n = 62	Apremilast 30 mg n = 58	Apremilast 40 mg n = 63
Value	-10.98 (6.873)	-25.99 (7.106)	-31.57 (6.820)

Placebo vs Apremilast 30 mg: LS Mean Difference: -15.01 (95% CI -34.52 to 4.50), p = 0.1308, ANCOVA
Placebo vs Apremilast 40 mg: LS Mean Difference: -20.60 (95% CI -39.70 to -1.50), p = 0.0347, ANCOVA

Population analysed: All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Weeks 0-12)	0 of 64 (0%)	14 of 64 (21.9%)	Not reported
Apremilast 30 mg (Weeks 0-12)	1 of 58 (1.7%)	22 of 58 (37.9%)	Not reported
Apremilast 40 mg (Weeks 0-12)	2 of 63 (3.2%)	30 of 63 (47.6%)	Not reported
Apremilast 30 mg (Apremilast Exposure Period) 0-24	2 of 82 (2.4%)	30 of 82 (36.6%)	Not reported
Apremilast 40 mg (Apremilast Exposure Period) 0-24	3 of 86 (3.5%)	45 of 86 (52.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30528828Simpson EL, Imafuku S, Poulin Y, Ungar B, Zhou L, Malik K, Wen HC, Xu H, Estrada YD, Peng X, Chen M, Shah N, Suarez-Farinas M, Pavel AB, Nograles K, Guttman-Yassky E. A Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis. J Invest Dermatol. 2019 May;139(5):1063-1072. doi: 10.1016/j.jid.2018.10.043. Epub 2018 Dec 5.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Related trials for Dermatitis, Atopic Dermatitis

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RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
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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

31 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apremilast in people with Dermatitis, Atopic Dermatitis, run by Amgen at 31 sites in 3 countries.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Japan, Canada. 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 12 Dec 2016). 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?

Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. (time frame: Baseline to Week 12). 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 NCT02087943, 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 7 May 2020.