Seborrheic DermatitisPhase 2NCT04445987

Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

A Phase 2 study testing ARQ-154 in people with Seborrheic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 39 sites in United States.

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

Who is it for?: Ages 9 years and older
Conditions the study is for: Seborrheic Dermatitis
What is being tested?: ARQ-154
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 408 participants
Where: 39 sitesUnited States
Study dates: 12 Jun 2020to 19 Nov 2022
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 9 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 or (for adolescents) assent.
Males and females ages 9 years and older (inclusive) at the time of consent.
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
Cohort 1 only:
Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.

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Cohort 2 subjects that have not participated in a prior ARQ-154 study:
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1.
Cohort 2 subjects that have participated in a prior ARQ-154 study:
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

Who cannot join

Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
Subjects unable to apply investigational product to the scalp due to physical limitation.
Known allergies to excipients in ARQ-154 foam.
Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
Known or suspected:

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severe renal insufficiency or moderate to severe hepatic disorders
history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
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 drugs abuse within 6 months of initiation of investigational product.
Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
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.
Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects.
Cohort 1 only:
Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
Subjects that use any Excluded Medication and Treatments.
Cohort 2 only:
Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.
Subjects with PHQ-8 >10 or modified PHQ-A >10 at Screening or Day 1.
Cohort 2 subjects that have participated in a prior ARQ-154 study:
Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

United States39 sites

Arcutis Biotherapeutics Clinical Site 13
Arlington, Texas, 76011
Arcutis Biotherapeutics Clinical Site 11
Austin, Texas, 78759
Arcutis Biotherapeutics Clinical Site 53
Aventura, Florida, 33180
Arcutis Biotherapeutics Clinical Site 59
Beverly Hills, California, 90212
Arcutis Biotherapeutics Clinical Site 18
Bexley, Ohio, 43209
Arcutis Biotherapeutics Clinical Site 73
Brighton, Massachusetts, 02135
Arcutis Biotherapeutics Clinical Site 76
Charleston, South Carolina, 29407
Arcutis Biotherapeutics Clinical Site 40
Clinton Township, Michigan, 48038
Arcutis Biotherapeutics Clinical Site 41
College Station, Texas, 77845
Arcutis Biotherapeutics Clinical Site 42
Coral Gables, Florida, 33134
Arcutis Biotherapeutics Clinical Site 57
Delray Beach, Florida, 33484
Arcutis Biotherapeutics Clinical Site 20
Detroit, Michigan, 48202
Arcutis Biotherapeutics Clinical Site 51
Encino, California, 91436
Arcutis Biotherapeutics Clinical Site 58
Fort Gratiot, Michigan, 48059
Arcutis Biotherapeutics Clinical Site 75
Fountain Valley, California, 92708
Arcutis Biotherapeutics Clinical Site 19
Fremont, California, 94538
Arcutis Biotherapeutics Clinical Site 14
Fridley, Minnesota, 55432
Arcutis Biotherapeutics Clinical Site 23
High Point, North Carolina, 27262
Arcutis Biotherapeutics Clinical Site 25
Houston, Texas, 77056
Arcutis Biotherapeutics Clinical Site 50
Las Vegas, Nevada, 89148
Arcutis Biotherapeutics Clinical Site 62
Los Angeles, California, 90036
Arcutis Biotherapeutics Clinical Site 15
Louisville, Kentucky, 40217
Arcutis Biotherapeutics Clinical Site 52
Metairie, Louisiana, 70006
Arcutis Biotherapeutics Clinical Site 24
Miami, Florida, 33144
Arcutis Biotherapeutics Clinical Site 55
New York, New York, 10029
Arcutis Biotherapeutics Clinical Site 17
Norfolk, Virginia, 23502
Arcutis Biotherapeutics Clinical Site 26
Pflugerville, Texas, 78660
Arcutis Biotherapeutics Clinical Site 27
Pittsburgh, Pennsylvania, 15213
Arcutis Biotherapeutics Clinical Site 22
Plainfield, Indiana, 46168
Arcutis Biotherapeutics Clinical Site 29
Portland, Oregon, 97210
Arcutis Biotherapeutics Clinical Site 56
Portsmouth, New Hampshire, 03801
Arcutis Biotherapeutics Clinical Site 28
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 10
Rolling Meadows, Illinois, 60008
Arcutis Biotherapeutics Clinical Site 54
San Antonio, Texas, 78213
Arcutis Biotherapeutics Clinical Site 64
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 65
Sanford, Florida, 32771
Arcutis Biotherapeutics Clinical Site 21
Santa Monica, California, 90404
Arcutis Biotherapeutics Clinical Site 12
Tampa, Florida, 33613
Arcutis Biotherapeutics Clinical Site 63
The Bronx, New York, 10462

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis

This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.

Conditions: Seborrheic Dermatitis
Being tested: ARQ-154
Medical subject headings: Dermatitis, Seborrheic

What participants receive

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

ARQ-154Drug
ARQ-154 foam 0.3% applied once daily for 52 weeks

Study groups in NCT04445987
Study group	Role	What they receive
Long-term safety of ARQ-154	Experimental	Open-label, Long-term Safety of ARQ-154 Receives: Drug: ARQ-154

What is being measured

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

Number of Participants With ≥1 Adverse Event (AE)
The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Measured: Up to 52 weeks
Number of Participants With ≥1 Serious Adverse Event (SAE)
The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Measured: Up to 52 weeks

Secondary outcomes (4)

Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear
The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Measured: Weeks 4, 12, 24, 36, and 52
Achievement of IGA Success
The number of participants achieving "success" in IGA assessment of disease severity is presented. 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 seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Measured: Weeks 4, 12, 24, 36, and 52
Duration of IGA Success
The duration of "success" in IGA assessment of disease severity is presented. 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 seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date.
Measured: Weeks 4, 12, 24, 36, and 52
IGA Treatment-Free Interval
The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 ["completely clear"]) and stops treatment of all lesions until the time of restarting treatment.
Measured: Weeks 4, 12, 24, 36, and 52

Timeline

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

12 Jun 202019 Nov 2022

First posted24 Jun 2020
Study start12 Jun 2020
Primary completion19 Nov 2022
Study completion19 Nov 2022

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 Seborrheic 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)
Masking: None (open label)
Enrolment: 408 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04445987
Sponsor's protocol ID: ARQ-154-214
Status last verified: May 2024
First submitted: 22 Jun 2020
Last updated: 11 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Alexis AF, Bukhalo M, Cook-Bolden FE, Del Rosso JQ, Draelos ZD, DuBois JC, Ferris LK, Forman SB, Kempers SE, Kircik LH, Lain E, Moore AY, Pariser DM, Raoof J, Zirwas MJ, Seal MS, Kato S, Chu DH, Krupa D, Snyder S, Burnett P, Berk DR. Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks. Am J Clin Dermatol. 2026 Jan;27(1):189-198. doi: 10.1007/s40257-025-00984-2. Epub 2025 Nov 1.
PubMed 41175336

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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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis
ClinicalTrials.gov ID: NCT04445987
Acronym / sponsor ID: ARQ-154-214
Conditions: Seborrheic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 408 participants (actual)
Lead sponsor: Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 12 Jun 2020 (actual)
Primary completion: 19 Nov 2022 (actual)
Study completion: 19 Nov 2022 (actual)
First posted: 24 Jun 2020 (actual)
Results: Posted 11 Jun 2024

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)

Arm	Type	Receives
Long-term safety of ARQ-154	Experimental	Drug: ARQ-154Open-label, Long-term Safety of ARQ-154

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (14 listed)

Participants legally competent to sign and give informed consent or (for adolescents) assent.
Males and females ages 9 years and older (inclusive) at the time of consent.
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.

Key exclusion criteria (22 listed)

Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
Subjects unable to apply investigational product to the scalp due to physical limitation.
Known allergies to excipients in ARQ-154 foam.
Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.

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
ARQ-154ARQ-154 foam 0.3% applied once daily for 52 weeks	Drug	Long-term safety of ARQ-154

Primary outcome

Number of Participants With ≥1 Adverse Event (AE)
Time frame: Up to 52 weeks
The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Number of Participants With ≥1 Serious Adverse Event (SAE)
Time frame: Up to 52 weeks
The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.

4 secondary outcomes

Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear
Time frame: Weeks 4, 12, 24, 36, and 52
Achievement of IGA Success
Time frame: Weeks 4, 12, 24, 36, and 52
Duration of IGA Success
Time frame: Weeks 4, 12, 24, 36, and 52
IGA Treatment-Free Interval
Time frame: Weeks 4, 12, 24, 36, and 52

Results and safety

Results posted to the registry on 11 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	52	43
Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap	23	20
Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap	41	37
Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap	17	16
Cohort 2 Group 4: De Novo Participants	267	211
Cohort 1 Group 2: ARQ-154-116 Rollover	8	7

Primary outcome: Number of Participants With ≥1 Adverse Event (AE)

Time frame: Up to 52 weeks. Count of participants. Unit: Participants

Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n = 75	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n = 58	Cohort 2 Group 4: De Novo Participants n = 267	Cohort 1 Group 2: ARQ-154-116 Rollover n = 8
Value	17	23	90	3

Population analysed: All participants are included.

Primary outcome: Number of Participants With ≥1 Serious Adverse Event (SAE)

Time frame: Up to 52 weeks. Count of participants. Unit: Participants

Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n = 75	Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n = 58	Cohort 2 Group 4: De Novo Participants n = 267	Cohort 1 Group 2: ARQ-154-116 Rollover n = 8
Value	2	0	5	0

Population analysed: All participants are included.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	2 of 75 (2.7%)	3 of 75 (4%)	0 of 75
Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	0 of 58 (0%)	4 of 58 (6.9%)	0 of 58
Cohort 2 Group 4: De Novo Participants	5 of 267 (1.9%)	11 of 267 (4.1%)	1 of 267
Cohort 1 Group 2: ARQ-154-116 Rollover	0 of 8 (0%)	6 of 8 (75%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41175336Alexis AF, Bukhalo M, Cook-Bolden FE, Del Rosso JQ, Draelos ZD, DuBois JC, Ferris LK, Forman SB, Kempers SE, Kircik LH, Lain E, Moore AY, Pariser DM, Raoof J, Zirwas MJ, Seal MS, Kato S, Chu DH, Krupa D, Snyder S, Burnett P, Berk DR. Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks. Am J Clin Dermatol. 2026 Jan;27(1):189-198. doi: 10.1007/s40257-025-00984-2. Epub 2025 Nov 1.
Individual participant dataSharing planned: No

Related trials for Seborrheic Dermatitis

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TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
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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.

David Berk, MD study director

Arcutis Biotherapeutics

39 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARQ-154 in people with Seborrheic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 39 sites 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 14 inclusion and 22 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites 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 11 Jun 2024). 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 With ≥1 Adverse Event (AE) (time frame: Up to 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04445987, 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 11 Jun 2024.