Chronic Plaque PsoriasisPhase 3DERMIS-1NCT04211363
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
A Phase 3 study testing Roflumilast 0.3% cream in people with Chronic Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 40 sites in 2 countries.
Trial summary
This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- Roflumilast 0.3% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 439 participants
- Where
- 40 sitesin 2 countries
- Study dates
- 20 Dec 2019to 16 Nov 2020
- Phase
- Phase 3
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws
- Males and females ages 2 years and older (inclusive)
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
- Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
- In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
- Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Who cannot join
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with ARQ-151 or its active ingredient
- Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
- Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States31 sites
Arcutis Biotherapeutics Clinical Site 111
Baton Rouge, Louisiana, 70809
Arcutis Biotherapeutics Clinical Site 101
Brighton, Massachusetts, 02135
Arcutis Biotherapeutics Clinical Site 116
Clinton Township, Michigan, 48038
Arcutis Biotherapeutics Clinical Site 104
College Station, Texas, 77845
Arcutis Biotherapeutics Clinical Site 119
Dallas, Texas, 75246
Arcutis Biotherapeutics Clinical Site 118
Delray Beach, Florida, 33484
Arcutis Biotherapeutics Clinical Site 128
Duncansville, Pennsylvania, 16635
Arcutis Biotherapeutics Clinical Site 129
East Windsor, New Jersey, 08520
Arcutis Biotherapeutics Clinical Site 127
Encinitas, California, 92024
Arcutis Biotherapeutics Clinical Site 113
Exton, Pennsylvania, 19003
Arcutis Biotherapeutics Clinical Site 124
Fairborn, Ohio, 45324
Arcutis Biotherapeutics Clinical Site 112
Fremont, California, 94538
Arcutis Biotherapeutics Clinical Site 115
High Point, North Carolina, 27262
Arcutis Biotherapeutics Clinical Site 120
Irvine, California, 92697
Arcutis Biotherapeutics Clinical Site 131
Miami, Florida, 33174
Arcutis Biotherapeutics Clinical Site 121
New York, New York, 10029
Arcutis Biotherapeutics Clinical Site 137
Ocala, Florida, 34470
Arcutis Biotherapeutics Clinical Site 134
Oklahoma City, Oklahoma, 73118
Arcutis Biotherapeutics Clinical Site 135
Pittsburgh, Pennsylvania, 15213
Arcutis Biotherapeutics Clinical Site 114
Plainfield, Illinois, 46168
Arcutis Biotherapeutics Clinical Site 139
Reno, Nevada, 89509
Arcutis Biotherapeutics Clinical Site 130
Rochester, New York, 14623
Arcutis Biotherapeutics Clinical Site 125
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 138
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 102
Rolling Meadows, Illinois, 60008
Arcutis Biotherapeutics Clinical Site 110
San Antonio, Texas, 78218
Arcutis Biotherapeutics Clinical Site 117
San Antonio, Texas, 78229
Arcutis Biotherapeutics Clinical Site 123
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 136
San Francisco, California, 94132
Arcutis Biotherapeutics Clinical Site 105
Sanford, Florida, 32771
Arcutis Biotherapeutics Clinical Site 108
Stony Brook, New York, 11790
Canada9 sites
Arcutis Biotherapeutics Clinical Site 132
Calgary, Alberta, T1Y 0B4
Arcutis Biotherapeutics Clinical Site 103
London, Ontario, N6H 5L5
Arcutis Biotherapeutics Clinical Site 122
Markham, Ontario, L3P 1X2
Arcutis Biotherapeutics Clinical Site 133
Mississauga, Ontario, L5H 1G9
Arcutis Biotherapeutics Clinical Site 107
Montreal, Quebec, H3Z 2S6
Arcutis Biotherapeutics Clinical Site 140
Ottawa, Ontario, K2C 3N2
Arcutis Biotherapeutics Clinical Site 109
Peterborough, Ontario, K9J 5K2
Arcutis Biotherapeutics Clinical Site 126
Québec, Quebec, G1V4X7
Arcutis Biotherapeutics Clinical Site 106
Waterloo, Ontario, N2J 1C4
About this study
Official title: A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Roflumilast 0.3% cream, Vehicle Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 0.3% creamDrug
Also called ARQ-151
Roflumilast 0.3% cream for topical application.
Vehicle CreamDrug
Vehicle cream for topical application.
| Study group | Role | What they receive |
|---|---|---|
| Rofumilast Cream 0.3% | Experimental | Participants receive roflumilast cream 0.3% once daily for 8 weeks. Receives: Drug: Roflumilast 0.3% cream |
| Vehicle cream | Placebo comparator | Participants receive vehicle cream once daily for 8 weeks. Receives: Drug: Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Measured: Baseline (Day 1) and Week 8
Secondary outcomes (7)
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The time to achieve PASI-50 (defined as a 50% reduction from baseline in PASI score) is presented, and is based on observed data only.
Measured: From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 days)
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. The number of participants achieving PASI-75 (defined as a 75% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Measured: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) [higher scores indicate greater symptom severity]. The number of participants achieving PASI-90 (defined as a 90% reduction from baseline in PASI score) at Week 8 is presented. Participant counts are based on observed data only.
Measured: Baseline (Day 1) and Week 8
Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8
The number of participants achieving I-IGA success at Week 8 is presented. Success is defined as achievement of I-IGA score of 0 ('clear') or 1 ('almost clear') at Week 8 PLUS a ≥2-grade improvement in score from Baseline. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis in the intertriginous area, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater symptom severity. Participant counts are based on observed data only.
Measured: Baseline (Day 1) and Week 8
Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8
The number of participants achieving an IGA score of 0 ('clear') at Week 8 is presented (observed data only) for each arm. The I-IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'); higher scores indicate greater symptom severity.
Measured: Week 8
Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success
The number of participants achieving success in WI-NRS is presented. Success is defined as achievement of a ≥ 4-point reduction in WI-NRS pruritus score in participants with WI-NRS pruritus score ≥ 4 at baseline. The WI-NRS is a 10 point scale ranging from 0 ('no itch') to 10 ('worst itch imaginable'), with higher scores indicating greater symptoms severity. Results are based on observed data only.
Measured: Baseline (Day 1) and Weeks 2, 4, and 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The least squares (LS) mean (95% CI) change in PSD total score relative to baseline is presented for each treatment arm, with decreases from baseline indicating symptom improvement.
Measured: Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start20 Dec 2019
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
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 (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211363
- Sponsor's protocol ID
- ARQ-151-301
- Acronym
- DERMIS-1
- Status last verified
- Dec 2022
- First submitted
- 23 Dec 2019
- Last updated
- 7 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papp KA, Del Rosso JQ, Lebwohl MG, Gooderham MJ, Hebert AA, Hong HC, Kircik LH, Pariser DM, Stein Gold L, Strober B, Seal MS, Krupa D, Chu DH, Burnett P, Berk DR, Higham RC. Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3733-3744. doi: 10.1007/s13555-025-01562-4. Epub 2025 Oct 24.
PubMed 41134450Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.
PubMed 36422852Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.
PubMed 36125472
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04211363
- Acronym / sponsor ID
- DERMIS-1 / ARQ-151-301
- Conditions
- Chronic Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rofumilast Cream 0.3% | Experimental | Drug: Roflumilast 0.3% creamParticipants receive roflumilast cream 0.3% once daily for 8 weeks. |
| Vehicle cream | Placebo comparator | Drug: Vehicle CreamParticipants receive vehicle cream once daily for 8 weeks. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws
- Males and females ages 2 years and older (inclusive)
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
- Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
- In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
Key exclusion criteria (6 listed)
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with ARQ-151 or its active ingredient
- Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
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 |
|---|---|---|
| Roflumilast 0.3% creamAlso: ARQ-151Roflumilast 0.3% cream for topical application. | Drug | Rofumilast Cream 0.3% |
| Vehicle CreamVehicle cream for topical application. | Drug | Vehicle cream |
Primary outcome
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
Time frame: Baseline (Day 1) and Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
7 secondary outcomes
Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
Time frame: From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 days)
Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8
Time frame: Baseline (Day 1) and Week 8
Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8
Time frame: Week 8
Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success
Time frame: Baseline (Day 1) and Weeks 2, 4, and 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
Time frame: Weeks 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41134450Papp KA, Del Rosso JQ, Lebwohl MG, Gooderham MJ, Hebert AA, Hong HC, Kircik LH, Pariser DM, Stein Gold L, Strober B, Seal MS, Krupa D, Chu DH, Burnett P, Berk DR, Higham RC. Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials. Dermatol Ther (Heidelb). 2025 Dec;15(12):3733-3744. doi: 10.1007/s13555-025-01562-4. Epub 2025 Oct 24.
- Derived from this study: PubMed 36422852Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.
- Derived from this study: PubMed 36125472Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast 0.3% cream in people with Chronic Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 40 sites in 2 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 6 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Nov 2022). 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 Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8 (time frame: Baseline (Day 1) and Week 8). 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 NCT04211363, which also lists 3 linked publications.
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 Dec 2022.