Atopic DermatitisPhase 1NCT04090229

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis

A Phase 1 study testing ASLAN004 in people with Atopic Dermatitis, run by ASLAN Pharmaceuticals at 11 sites in 3 countries.

Completed

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

Official record

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Trial summary

A Phase 1B, multi-center, double-blind, placebo-controlled, randomized, multiple ascending dose (MAD) clinical study is designed to evaluate ASLAN004 versus placebo in patients who have moderate-severe AD. The treatment period duration will be 8 weeks with a 12-week follow-up period after the end of treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atopic Dermatitis
What is being tested?: ASLAN004
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 11 sitesin 3 countries
Study dates: 9 Sep 2019to 3 Dec 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients who are of or older than the legal age in participating countries, who are able to read and understand, and willing to sign the informed consent form.
Willing and able to comply with clinic visits and study-related procedures.
Have a clinical diagnosis of chronic atopic dermatitis (per Eichenfield revised criteria of Hanifin and Rajka) that has been present for at least 3 years before the screening visit.
Have an IGA score of ≥3 at the screening and baseline visits.
Have ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.
Have an EASI score ≥16 at the screening and baseline visits.
Have a history of inadequate response to a stable (≥1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit.
Have applied a stable dose of an additive, basic, bland topical emollient (moisturizer) twice daily for at least 7 days before Randomization.

Who cannot join

Have received previous treatment with therapeutic agents targeting ligand or receptors of IL-4 or IL-13, including but not limited to dupilumab, lebrikizumab, or tralokinumab.
Have inadequate organ and hematological function at the screening visit (as per protocol)
Have uncontrolled blood pressure at the screening visit based on clinical judgment of the Investigator.
Have a chest radiograph at Screening or within 3 months before the screening visit with results consistent with prior or current tuberculosis infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non caseating granulomata. QuantiFERON gold standard may be conducted per standard practice at the site.
Have a known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection or positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody HBcAb), positive Hepatitis C antibody (HCV) at the screening visit.
Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jiroveci, aspergillosis despite infection resolution; JC virus (progressive multifocal leukoencephalopathy).

Show all 27Show fewer

Have received treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before Randomization.
Have received treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products (eg., Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 1 week before Randomization.
Have had systemic treatment for AD with cyclosporine, mycophenolate-mofetil, interferon gamma (IFN-γ), phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), azathioprine, or methotrexate within 4 weeks before Randomization.
Have had treatment with leukotriene inhibitors within 4 weeks before Randomization.
Have had treatment with systemic corticosteroids within 4 weeks before Randomization.
Have had treatment with small molecule investigational drugs (eg., tofacitinib) within 8 weeks before Randomization.
Have had treatment with biologics other than those targeting ligand or receptors of IL-4 or IL-13 within 8 weeks before Randomization.
Have had treatment with live attenuated vaccine within 8 weeks before Randomization.
Have had treatment with allergen immunotherapy within 6 months before Randomization.
Have had a regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
Requirement of more than 2 bleach baths per week during study participation.
Have chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the screening visit, or superficial skin infections within 1 week before the screening visit.
Presence of skin comorbidities that may interfere with study assessments.
Have a clinically significant history or evidence of any active or suspected parasitic infection (other than treated trichomoniasis) within the 4 weeks before Randomization or has travelled within the past 3 months of Randomization to areas of high parasitic exposure (based on Centers for Disease Control and Prevention [CDC] travel notice alert Level 2 and warning Level 3).
Have a history of malignancy within 5 years before Randomization with the following exceptions: patient with a history of cured in situ carcinoma of the cervix, and/or non-metastatic squamous or basal cell carcinoma of the skin are allowed.
Have any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor's Medical Monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results.
Have a history of alcohol or drug abuse within 2 years of the screening visit.
Have scheduled or anticipate any surgical procedure during study participation and/or hospitalization for any reason within 60 days of Screening.
Pregnant or breastfeeding women.
Patients who are unwilling to use adequate birth control, if of reproductive potential and sexually active. For females, adequate birth control implies: use of hormonal contraceptives, intrauterine devices (IUD), or double barrier contraception (condom + diaphragm, condom or diaphragm + spermicidal gel or foam). For males, adequate birth control implies: use of double barrier contraception (condom + diaphragm, condom or diaphragm + spermicidal gel or foam). Abstinence is also accepted if this is the normal habit of the patient.
Patients who are dependent on prescription moisturizers.

Trial locations and contacts

11 sites in 3 countries.

Country

City, postcode or hospital

11 sites in 3 countries

United States5 sites

Dermatology Treatment and Research Cancer
Dallas, Texas, 75230
Center for Dermatology Clinical Research, INC
Fremont, California, 94538
First OC Dermatology
Los Angeles, California, 92708
Direct Helpers Research Center
Miami, Florida, 33012
Paddington Testing Co, INC
Philadelphia, Pennsylvania, 19103

Other trials in United States

Australia4 sites

Skin Health Institute, Inc.
Carlton, Victoria, 3053
Fremantle Dermatology
Fremantle, Western Australia, 6160
Premier Specialists Pty Ltd
Kogarah, New South Wales, 2217
Veracity Clinical Research Pty Ltd
Woolloongabba, Queensland, 4102

Other trials in Australia

Singapore2 sites

National Skin Centre
Singapore, 308205
Changi General Hospital
Singapore, 529889

Other trials in Singapore

About this study

Read the detailed description

The study is designed as a MAD escalation in up to 3 cohorts of patients, followed by a cohort expansion to further confirm the safety and tolerability of the selected dose, prior to further investigation in Phase 2 studies. The cohort expansion will also support the assessment of the trial's secondary efficacy objectives. Approximately 50 patients are planned to be enrolled across the entire study.

Approximately 24 patients are planned to be enrolled in the initial MAD escalation, with a maximum of 3 ascending dose levels (low, medium and high) of ASLAN004 (Cohorts 1-3). In all dose cohorts, 8 patients will be randomized in a 3:1 ratio to receive ASLAN004 (at specified cohort dose, n=6) or matching placebo (n=2). Additional cohorts may be optional depending on the data from the preceding cohort.

An expansion cohort (Cohort 4) of approximately 27 patients is planned and will be randomized in a 2:1 ratio to receive ASLAN004 (n=18) or matching placebo (n=9). The rationale for this is to provide greater assurance about the safety and tolerability of the selected dose level, and to provide preliminary estimates of the PD and clinical effects at this dose, prior to further dose and schedule finding work in Phase 2 studies.

A total of 8 subcutaneous injections of ASLAN004 or matching placebo will be administered according to a weekly schedule of injection from Day 1 (baseline visit) to Day 50 (Week 7) of the study. Patients will be closely monitored and observed for a period of 30 minutes after each injection of study drug (all visits). The clinical assessments and blood sampling for safety laboratory tests, PK analysis, ADA assays, and biomarkers will be performed at each visit as noted in the Schedule of Assessments. The treatment period will end at the last day of Week 8 (ie., Day 56) after which patients will be followed every week for 12 weeks for safety, PK parameters, ADA, and PD marker assessments. In the event that patients develop adverse events (AEs)/serious AEs (SAEs) which are determined as definitely related, probably related, or possibly related to ADA, and/or patients have a positive ADA result, additional unscheduled sampling of ADA may be performed during the study or after Day 141, as deemed clinically necessary. The exact timepoints for ADA sampling after Day 141 will be discussed between the Investigator and Sponsor for each case.

Conditions: Atopic Dermatitis
Being tested: ASLAN004, ASLAN004 Placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

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

ASLAN004Drug
Subcutaneous injections of ASLAN004 100 mg/mL will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.
ASLAN004 PlaceboDrug
Subcutaneous injections of ASLAN004 Placebo will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.

Study groups in NCT04090229
Study group	Role	What they receive
ASLAN004	Experimental	Not described Receives: Drug: ASLAN004
ASLAN004 Placebo	Placebo comparator	Not described Receives: Drug: ASLAN004 Placebo

What is being measured

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

To assess the safety and tolerability of multiple ascending doses of ASLAN004: Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs) reported from the administration of study drug on Day 1 until the completion of the study.
Measured: Baseline to 12 weeks safety follow up

Secondary outcomes (10)

Percentage change from baseline in Eczema Area and Severity Index (EASI) score weekly up to Week 8.
Measured: Baseline up to Week 8
Proportion of patients with 50%, 75%, and 90% improvement in the EASI score (EASI50, EASI75, and EASI90) weekly up to Week 8.
Measured: Baseline up to Week 8
Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8.
Measured: Baseline up to Week 8
Proportion of patients with at least a 4-point improvement in the Pruritus NRS score weekly up to Week 8.
Measured: Baseline up to Week 8
Proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 weekly up to Week 8.
Measured: Baseline up to Week 8
Percentage change from baseline in the Patient-Oriented Eczema Measure (POEM) weekly up to Week 8.
Measured: Baseline up to Week 8
Percentage change from baseline in percent body surface area (%BSA) affected weekly up to Week 8.
Measured: Baseline up to Week 8
PK parameters throughout the dosing period, and serum concentrations by scheduled timepoints.
Measurement of area under the curve (AUC) at Week 8 (AUC0-last), maximum observed concentration (Cmax) at Week 1, time to Cmax (tmax) at Week 1, Ctrough throughout the dosing period, and serum concentrations by scheduled timepoints.
Measured: Baseline to 12 weeks safety follow up
Change from baseline in PD markers of allergic inflammation (TARC and total IgE) weekly up to Week 8.
Measurement of absolute values of TARC and total IgE in serum concentration and percentage of change
Measured: Baseline up to Week 8
Measurement of ASLAN004 Anti-Drug Antibody over time.
Measurement of ADA levels in serum
Measured: Baseline to 12 weeks safety follow up

Timeline

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

9 Sep 20193 Dec 2021

First posted16 Sep 2019
Study start9 Sep 2019
Primary completion28 Oct 2021
Study completion3 Dec 2021

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 Atopic DermatitisStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Double Blind, Placebo-controlled, Randomized
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04090229
Sponsor's protocol ID: ASLAN004-002
Status last verified: Jan 2022
First submitted: 11 Sep 2019
Last updated: 12 Jan 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Cevikbas F, Ward A, Veverka KA. Eblasakimab, an Anti-IL-13Ralpha1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate-to-Severe Atopic Dermatitis. BioDrugs. 2024 Nov;38(6):821-830. doi: 10.1007/s40259-024-00685-y. Epub 2024 Oct 15.
PubMed 39404994

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

RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)

All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT04090229
Acronym / sponsor ID: ASLAN004-002
Conditions: Atopic Dermatitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: ASLAN PharmaceuticalsUniversity, hospital or other
Study start: 9 Sep 2019 (actual)
Primary completion: 28 Oct 2021 (actual)
Study completion: 3 Dec 2021 (actual)
First posted: 16 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Double Blind, Placebo-controlled, Randomized

Arm	Type	Receives
ASLAN004	Experimental	Drug: ASLAN004
ASLAN004 Placebo	Placebo comparator	Drug: ASLAN004 Placebo

Who may qualify

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

Key inclusion criteria (8 listed)

Adult patients who are of or older than the legal age in participating countries, who are able to read and understand, and willing to sign the informed consent form.
Willing and able to comply with clinic visits and study-related procedures.
Have a clinical diagnosis of chronic atopic dermatitis (per Eichenfield revised criteria of Hanifin and Rajka) that has been present for at least 3 years before the screening visit.
Have an IGA score of ≥3 at the screening and baseline visits.
Have ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits.

Key exclusion criteria (27 listed)

Have received previous treatment with therapeutic agents targeting ligand or receptors of IL-4 or IL-13, including but not limited to dupilumab, lebrikizumab, or tralokinumab.
Have inadequate organ and hematological function at the screening visit (as per protocol)
Have uncontrolled blood pressure at the screening visit based on clinical judgment of the Investigator.
Have a chest radiograph at Screening or within 3 months before the screening visit with results consistent with prior or current tuberculosis infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non caseating granulomata. QuantiFERON gold standard may be conducted per standard practice at the site.
Have a known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection or positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody HBcAb), positive Hepatitis C antibody (HCV) at the screening visit.

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
ASLAN004Subcutaneous injections of ASLAN004 100 mg/mL will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.	Drug	ASLAN004
ASLAN004 PlaceboSubcutaneous injections of ASLAN004 Placebo will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.	Drug	ASLAN004 Placebo

Primary outcome

To assess the safety and tolerability of multiple ascending doses of ASLAN004: Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to 12 weeks safety follow up
Incidence of treatment-emergent adverse events (TEAEs) reported from the administration of study drug on Day 1 until the completion of the study.

10 secondary outcomes

Percentage change from baseline in Eczema Area and Severity Index (EASI) score weekly up to Week 8.
Time frame: Baseline up to Week 8
Proportion of patients with 50%, 75%, and 90% improvement in the EASI score (EASI50, EASI75, and EASI90) weekly up to Week 8.
Time frame: Baseline up to Week 8
Percentage change from baseline in the Pruritus Numerical Rating Scale (NRS) score weekly up to Week 8.
Time frame: Baseline up to Week 8
Proportion of patients with at least a 4-point improvement in the Pruritus NRS score weekly up to Week 8.
Time frame: Baseline up to Week 8
Proportion of patients who achieve an Investigator Global Assessment (IGA) score of 0 or 1 weekly up to Week 8.
Time frame: Baseline up to Week 8
Percentage change from baseline in the Patient-Oriented Eczema Measure (POEM) weekly up to Week 8.
Time frame: Baseline up to Week 8
Percentage change from baseline in percent body surface area (%BSA) affected weekly up to Week 8.
Time frame: Baseline up to Week 8
PK parameters throughout the dosing period, and serum concentrations by scheduled timepoints.
Time frame: Baseline to 12 weeks safety follow up
Change from baseline in PD markers of allergic inflammation (TARC and total IgE) weekly up to Week 8.
Time frame: Baseline up to Week 8
Measurement of ASLAN004 Anti-Drug Antibody over time.
Time frame: Baseline to 12 weeks safety follow up

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 12 Jan 2022.
Derived from this study: PubMed 39404994Cevikbas F, Ward A, Veverka KA. Eblasakimab, an Anti-IL-13Ralpha1 Antibody, Reduces Atopy-Associated Serum Biomarkers in Moderate-to-Severe Atopic Dermatitis. BioDrugs. 2024 Nov;38(6):821-830. doi: 10.1007/s40259-024-00685-y. Epub 2024 Oct 15.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASLAN004 in people with Atopic Dermatitis, run by ASLAN Pharmaceuticals at 11 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 8 inclusion and 27 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 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Australia, Singapore. 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 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?

To assess the safety and tolerability of multiple ascending doses of ASLAN004: Incidence of treatment-emergent adverse events (TEAEs) (time frame: Baseline to 12 weeks safety follow up). 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 NCT04090229, 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 12 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.