Papulopustular RosaceaPhase 2NCT06532136
Deucravacitinib Rosacea
A Phase 2 study testing Deucravacitinib in people with Papulopustular Rosacea, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This will be a double-blind, randomized placebo-controlled study in which participants will be randomized 2:1 to receive 6 mg deucravacitinib or placebo once daily for 8 weeks, followed by an open label extension during which all participants will receive 6 mg deucravacitinib once daily for an additional 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- Deucravacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2024to Jan 2026
- Phase
- Phase 2
- 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
- Male or female participants ≥ 18 years of age at the time of signing the informed consent document.
- Participant is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
- Participant is able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12
- Participant agrees to discontinue all treatments for PPR from screening through study completion aside from the study drug
- Participant is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a participant does not have uncontrolled significant co-morbid conditions).
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- Participant agrees not to receive a live vaccine during the study and for at least 4 weeks after the last study drug dose.
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last dose of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy OR
- Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- The female participant's chosen form of contraception must be effective by the time the female participant is enrolled into the study.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- Participants with other skin diseases that would interfere with the study assessment in the opinion of the investigator.
- Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation.
- Participants has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB, HIV, HBV, HCV, thromboembolic events) that will affect the health of the participant during the study or interfere with the interpretation of study results.
- Participant has previously received treatment with TYK2 inhibitor
- Current topical or oral treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical metronidazole, topical minocycline, topical ivermectin, topical azelaic acid, topical brimonidine, topical oxymetazoline oral antibiotics) within 2 weeks of baseline
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- Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus within 4 weeks of study initiation
- History of adverse systemic or allergic reactions to any component of the study drug.
- Current participation in any other study with an investigational medication
- Participant who is pregnant or breast feeding or plans on becoming pregnant or breastfeeding
- Participant has received a live vaccine < 4 weeks of Baseline/Week 0 visit.
- ANY of the following abnormalities in the clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary
- Absolute neutrophil count of <1.2 x 109/L (<1200/mm3);
- Hemoglobin <11.0 g/dL or hematocrit <33%;
- Platelet count of <150 x 109/L (<150,000/mm3);
- Absolute lymphocyte count of <0.80 x 109 /L (<800/mm3);
- Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/ml/min/1.73m2 based on CKD-Epi 2021 (creatine equation);
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >2 times the ULN;
- Total bilirubin ≥ 1.5 times the ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ≤ ULN
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Treatment of Moderate-to-severe Papulopustular Rosacea With Deucravacitinib
This will be a double-blind, randomized placebo-controlled study in which participants will be randomized 2:1 to receive 6 mg deucravacitinib or placebo once daily for 8 weeks, followed by an open label extension during which all participants will receive 6 mg deucravacitinib once daily for an additional 8 weeks. The open-label extension has been incorporated in order to ensure all participants receive benefit from the study, as well as to benefit from the intra-patient comparison of placebo to drug, and to provide longer-term clinical data.
The study will include 33 adult participants with moderate-to-severe Papulopustular Rosacea (PPR). participants will have baseline Investigator Global Assessment (IGA) score of at least 3 and at least 12 inflammatory lesions.
Beginning at Baseline/Week 0 enrolled participants will receive 6mg deucravacitinib or placebo once daily for 8 weeks. At week 8, those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16. All participants will return for visits at Weeks 4, 8, 12 and 16 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip collection, blood and urine sample collections, and monitoring for adverse events.
Read the detailed description
After providing consent, all subjects will be assessed for study eligibility, which includes a review of the subjects past and current medical conditions, familial medical history and detailed review of past and current medications. Subjects will also undergo a review of past topical treatments/therapies for PPR, and clinical assessments (inflammatory lesion count, IGA, CEA, PSA). Subjects will have urine (for urinalysis) and blood (for Complete Blood Count with differential, Comprehensive Metabolic Panel, lipid panel, creatinine kinase, C-Reactive Protein, HIV, HCV and HBV) collected for safety analysis. In addition, subjects will be screened for tuberculosis via PPD or quantiferon gold testing, and pregnancy (if applicable) via serum pregnancy test.
- Conditions
- Papulopustular Rosacea
- Being tested
- Deucravacitinib, Placebo
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Deucravacitinib 6 mg orally once daily.
PlaceboDrug
Matching placebo orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Deucravacitinib | Active comparator | Participants receiving 6mg deucravacitinib once daily for 8 weeks. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16. Receives: Drug: Deucravacitinib |
| Placebo then Deucravacitinib | Active comparator | Participants receiving placebo once daily for 8 weeks. At week 8, those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16. Receives: Drug: Deucravacitinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in inflammatory lesion (papule/pustule) count
This outcome looks at the percent change in inflammatory lesion presence (papule/pustule) from Baseline and Week 8 in deucravacitinib-treated vs. placebo patients. Lesions will be physically counted.
Measured: Baseline and Week 8
Secondary outcomes (11)
Investigator Global Assessment (IGA) Success
IGA Success is defined by a clear (0) or almost clear (1) and a reduction from baseline of ≥ 2 points score of 0 or 1 at weeks 4, 8, 12, and 16 in deucravacitinib-treated patients.
IGA is a 5-point scale defined by the following parameters: 0 (clear), 1 (almost clear), 2 (mild disease), 3 (moderate disease), 4 (severe disease), with higher rating indicating more severe outcomes.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
The Clinical Erythema Assessment
The Clinical Erythema Assessment assesses the redness of skin. This outcome is measuring change in erythema.
It is defined by the following parameters: 0 - Clear (clear skin with no signs of erythema), 1 - Almost Clear (almost clear, slight redness), 2 - Mild (mild erythema; definite redness), 3 - Moderate (moderate erythema; marked redness), 4 - Severe (severe erythema; fiery redness). Higher rating indicates more severe outcomes.
Measured: Week 4, Week 4, Week 8, Week 12, Week 16
The Clinical Patient Severity Assessment
The Clinical Patient Severity Assessment assesses the patient's perspective of the redness of their skin. This outcome is measuring change in patient's perspective of erythema.
It is defined by the following parameters: 0 - Clear (clear of unwanted redness), 1 - Almost Clear (nearly clear of wanted redness), 2 - Mild (somewhat more redness than I prefer), 3 - Moderate (more redness than I prefer), 4 - Severe (completely unacceptable redness).
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change from baseline in The Dermatology Life Quality Index (DLQI
The Dermatology Life Quality Index (DLQI) measures how much the patient's rosacea has affected their life over the previous week. It is a 10 question instrument. This outcome is measuring change in quality of life impaired by rosacea.
The answer to each question is scored according to the following: Question unanswered - scored 0, Not relevant - scored 0, Not at all - scored 0, A little - scored 1, A lot - scored 2, Very much - scored 3. The DLQI is calculated by summing the score of each question. The maximum score is 30 and the minimum score is 0. A higher score represents a quality of life that is more impaired. Overall DLQI scores are defined as 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11 - 20 = very large effect on patient's life, 21 -30 = extremely large effect on patient's life.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change from baseline in Ocular Surface Disease Index (OSDI)
The Ocular Surface Disease Index (OSDI) is used for measuring dry eye disease in patients. This outcome is measuring change in dry eye disease and effect on vision-related function.
OSDI is a 12 question instrument. The answer to each question is scored according to the following: All of the time - scored 4, Most of the time - scored 3, Half of the time - scored 2, Some of the time - scored 1, None of the time - scored 0. OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change in Inflammatory (papule/pustule) lesion count
Change from Baseline and from Week 8 in inflammatory (papule/pustule) lesion count at Week 16. A lesser lesion count at Week 16 indicates disease improvement.
Measured: Baseline, Week 8, Week 16
Change from baseline in IGA score at 4, 8, 12, and 16 weeks
Change from Baseline in IGA score at Week 4, 8, 12, and 16.
IGA is a 5-point scale defined by the following parameters: 0 (clear), 1 (almost clear), 2 (mild disease), 3 (moderate disease), 4 (severe disease). A decrease in IGA indicated improvement in disease, while an increase in IGA indicates worsening disease.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Percent change from baseline in IGA score at 4, 8, 12, and 16 weeks
Percent change from Baseline in IGA score at Week 4, 8, 12, and 16.
IGA is a 5-point scale defined by the following parameters: 0 (clear), 1 (almost clear), 2 (mild disease), 3 (moderate disease), 4 (severe disease). A decrease in IGA indicated improvement in disease, while an increase in IGA indicates worsening disease.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Frequency Adverse Events (AEs)
Safety and tolerability will be evaluated from the frequency of AEs.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Duration of AEs
Safety and tolerability will be evaluated from the duration of AEs. This outcome will assess the safety of treatment.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Severity of AEs
Safety and tolerability will be evaluated from the severity of AEs.
Severity of AEs is measured through a grading system Common Terminology Criteria for Adverse Events (CTCAE), which assigns severity grades ranging from 1 to 5. The scale is as follows:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Potentially life-threatening Grade 5: Results in Death Mild is defined as not significantly interfering with the patient's usual function. Moderate is defined as interfering to some extent with the patient's usual function. Severe is defined as preventing the patient from performing their usual functions.
Measured: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study startNov 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: This study is being closed due to sponsor withdrawal of funding and support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular RosaceaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Benjamin Ungar, Icahn School of Medicine at Mount Sinai
- Investigators
- Benjamin Ungar, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532136
- Sponsor's protocol ID
- STUDY-24-00593
- Status last verified
- Jan 2025
- First submitted
- 29 Jul 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be provided as aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Moderate-to-severe Papulopustular Rosacea With Deucravacitinib
- ClinicalTrials.gov ID
- NCT06532136
- Acronym / sponsor ID
- STUDY-24-00593
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is being closed due to sponsor withdrawal of funding and support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 1 Aug 2024 (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.
This will be a double-blind, randomized placebo-controlled study in which participants will be randomized 2:1 to receive 6 mg deucravacitinib or placebo once daily for 8 weeks, followed by an open label extension during which all participants will receive 6 mg deucravacitinib once daily for an additional 8 weeks. The open-label extension has been incorporated in order to ensure all participants receive benefit from the study, as well as to benefit from the intra-patient comparison of placebo to drug, and to provide longer-term clinical data.
The study will include 33 adult participants with moderate-to-severe Papulopustular Rosacea (PPR). participants will have baseline Investigator Global Assessment (IGA) score of at least 3 and at least 12 inflammatory lesions.
Beginning at Baseline/Week 0 enrolled participants will receive 6mg deucravacitinib or placebo once daily for 8 weeks. At week 8, those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16. All participants will return for visits at Weeks 4, 8, 12 and 16 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip collection, blood and urine sample collections, and monitoring for adverse events.
Detailed description
After providing consent, all subjects will be assessed for study eligibility, which includes a review of the subjects past and current medical conditions, familial medical history and detailed review of past and current medications. Subjects will also undergo a review of past topical treatments/therapies for PPR, and clinical assessments (inflammatory lesion count, IGA, CEA, PSA). Subjects will have urine (for urinalysis) and blood (for Complete Blood Count with differential, Comprehensive Metabolic Panel, lipid panel, creatinine kinase, C-Reactive Protein, HIV, HCV and HBV) collected for safety analysis. In addition, subjects will be screened for tuberculosis via PPD or quantiferon gold testing, and pregnancy (if applicable) via serum pregnancy test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deucravacitinib | Active comparator | Drug: DeucravacitinibParticipants receiving 6mg deucravacitinib once daily for 8 weeks. Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16. |
| Placebo then Deucravacitinib | Active comparator | Drug: Deucravacitinib, Drug: PlaceboParticipants receiving placebo once daily for 8 weeks. At week 8, those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female participants ≥ 18 years of age at the time of signing the informed consent document.
- Participant is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
- Participant is able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12
- Participant agrees to discontinue all treatments for PPR from screening through study completion aside from the study drug
Key exclusion criteria (19 listed)
- Participants with other skin diseases that would interfere with the study assessment in the opinion of the investigator.
- Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation.
- Participants has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB, HIV, HBV, HCV, thromboembolic events) that will affect the health of the participant during the study or interfere with the interpretation of study results.
- Participant has previously received treatment with TYK2 inhibitor
- Current topical or oral treatments (e.g., topical corticosteroids, topical calcineurin inhibitors, topical JAK inhibitors, topical metronidazole, topical minocycline, topical ivermectin, topical azelaic acid, topical brimonidine, topical oxymetazoline oral antibiotics) within 2 weeks of 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 |
|---|---|---|
| DeucravacitinibDeucravacitinib 6 mg orally once daily. | Drug | Deucravacitinib, Placebo then Deucravacitinib |
| PlaceboMatching placebo orally once daily. | Drug | Placebo then Deucravacitinib |
Primary outcome
Percent change in inflammatory lesion (papule/pustule) count
Time frame: Baseline and Week 8
This outcome looks at the percent change in inflammatory lesion presence (papule/pustule) from Baseline and Week 8 in deucravacitinib-treated vs. placebo patients. Lesions will be physically counted.
11 secondary outcomes
Investigator Global Assessment (IGA) Success
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
The Clinical Erythema Assessment
Time frame: Week 4, Week 4, Week 8, Week 12, Week 16
The Clinical Patient Severity Assessment
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change from baseline in The Dermatology Life Quality Index (DLQI
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change from baseline in Ocular Surface Disease Index (OSDI)
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Change in Inflammatory (papule/pustule) lesion count
Time frame: Baseline, Week 8, Week 16
Change from baseline in IGA score at 4, 8, 12, and 16 weeks
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Percent change from baseline in IGA score at 4, 8, 12, and 16 weeks
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Frequency Adverse Events (AEs)
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Duration of AEs
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Severity of AEs
Time frame: Baseline, Week 4, Week 4, Week 8, Week 12, Week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. Results will be provided as aggregated data.
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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.
Benjamin Ungar principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deucravacitinib in people with Papulopustular Rosacea, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 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: withdrawn, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent change in inflammatory lesion (papule/pustule) count (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.