Progressive Familial Intrahepatic Cholestasis (PFIC)Phase 3NCT05543187

A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)

A Phase 3 study testing TAK-625 in people with Progressive Familial Intrahepatic Cholestasis (PFIC), run by Takeda at 8 sites in Japan.

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

The main aim of the study is to check if TAK-625 improves symptoms of Progressive Familial Intrahepatic Cholestasis (PFIC), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time. Read more about this study

Who is it for?: Ages 1 month and older
Conditions the study is for: Progressive Familial Intrahepatic Cholestasis (PFIC)
What is being tested?: TAK-625
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 8 sitesJapan
Study dates: 10 Jan 2023to 22 Jul 2025
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 1 month and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

The participant is Japanese male or female with a body weight >=3.0 kg and who is >=1 month of age at the time of informed consent.
The participant has a cholestasis as manifested by total serum bile acid (sBA) >=3^ upper limit of the normal range (ULN) (applies to the primary cohort only).
The participant has an average morning ItchRO (Obs) score >=1.5 during 4 consecutive weeks of the screening period, leading to the baseline visit (Week 0/Visit 2). Since it is difficult to evaluate pruritus in infants, participants <12 months of age at screening whose pruritus is unavoidably difficult to be evaluated are not necessarily required to meet the above score.
The caregiver has completed at least 21 valid* morning ItchRO (Obs) entries during 4 consecutive weeks of the screening period, leading to the baseline visit (Week 0/Visit 2) (*valid=completed and not answered as "I don't know"; the maximum allowed invalidreports=7, no more than 2 invalid reports during the last 7 days before the baseline visit [Week 0/Visit 2]).
The participant has a diagnosis of progressive familial intrahepatic cholestasis (PFIC) based on:
Chronic cholestasis as manifested by persistent (>6 months) pruritus in addition to biochemical abnormalities and/or pathological evidence of progressive liver disease. ( =<6 months is acceptable for participants <12 months of age).

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AND
For Primary cohort:
The participant has a genetic testing result consistent with disease-causing variation in ABCB11 (PFIC2), based on a genotyping.
For Supplemental cohort:
The participant has a genetic testing results consistent with disease causing variation in ATP8B1 (PFIC1), ABCB4 (PFIC3), or tight junction protein 2 gene (TJP2) (PFIC4), based on a genotyping.
The participant has a PFIC phenotype without a known mutation or with another known mutation not described above.
The PFIC participant has internal or external biliary diversion surgery history, and the internal or external biliary diversion surgery was reversed.
The participant (whenever possible) and caregiver are able to be contacted by phone for scheduled remote visits (participant contacts [phone calls]).
Both a caregiver and participant above the age of assent are capable of reading and understanding the questionnaires.
The same caregiver should be contacted during this study. The ItchRO (Obs) should be completed by the same caregiver for consistency during this study, even if the participant is an adult (over 18 years old).

Who cannot join

The diagnosed with PFIC2 due to ABCB11 mutation that predicts complete absence of BSEP function due to the type of ABCB11 mutation (t-PFIC2), based on a genotyping (applies to the primary cohort only).
The participant has a diagnosis of benign recurrent intrahepatic cholestasis indicated by a history of intermittent cholestasis with no disease progression.
The participant has a current or recent history (<1 year) of atopic dermatitis or other non-cholestatic diseases associated with pruritus.
The participant has a previous history of surgical interruption of the enterohepatic circulation (applies to the primary cohort only).
The participant with chronic diarrhea requiring intravenous (IV) fluid or nutritional intervention and/or its sequelae at screening or during the 6 months prior to screening.
The participant has a history of liver transplant or currently requires imminent liver transplant.

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The participant with decompensated cirrhosis (international normalized ratio [INR] >1.5, and/or albumin <30 g/L, history, or presence of clinically significant ascites, and/or variceal hemorrhage, and/or encephalopathy).
The participant has an alanine aminotransferase (ALT) or total serum bilirubin (TSB) level >15^ ULN at screening.
The participant has other liver disease.
The participant has any other disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, including bile salt metabolism in the intestine (eg, inflammatory bowel disease), per investigator discretion.
The participant has a possible malignant liver mass in imaging, including screening ultrasound.
The participant has received bile acid, lipid binding resins or ileal bile acid transporter (IBAT) inhibitors within 28 days prior to screening and throughout the trial.
The participant who has received sodium phenylbutyrate for less than 6 months at the initiation of screening.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Japan8 sites

Juntendo University Hospital
Bunkyo-ku, Tokyo
Kyushu University Hospital
Fukuoka
Kyoto University Hospital
Kyoto
Saitama Prefectural Children's Medical Center
Saitama
Osaka University Hospital
Suita, Osaka
University of Tsukuba Hospital
Tsukuba, Ibaraki
Tsuyama Chuo Hospital
Tsuyama, Okayama-ken
Yokohamashi Tobu Hospital
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-625 in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis

The participants will be treated with TAK-625 for up to the end of study (about 34 months).

Participants will visit their study clinic 15 times from the start of study. After 15 times visits, participants will visit their study clinic every 12 weeks up to the end of study.

Conditions: Progressive Familial Intrahepatic Cholestasis (PFIC)
Being tested: TAK-625
Medical subject headings: Cholestasis, progressive familial intrahepatic 1

What participants receive

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

TAK-625Drug
Also called Maralixibat chloride
TAK-625 orally, twice daily (BID)

Study groups in NCT05543187
Study group	Role	What they receive
TAK-625, Primary cohort	Experimental	TAK-625 orally, twice daily (BID) for 4 weeks as Dose Escalation Period. The dose in Dose Escalation Period will be increased weekly, 150 mcg/kilograms (kg), 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg. After Dose Escalation Period, TAK-625 600 mcg/kg (or maximum tolerated dose [MTD]), orally, BID up to study completion. Receives: Drug: TAK-625
TAK-625, Supplemental cohort	Experimental	TAK-625 orally, twice daily (BID) for 4 weeks as Dose Escalation Period. The dose in Dose Escalation Period will be increased weekly, 150 mcg/kilograms (kg), 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg. After Dose Escalation Period, TAK-625 600 mcg/kg (or maximum tolerated dose [MTD]), orally, BID up to study completion. Receives: Drug: TAK-625

What is being measured

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

Change in the Average Morning Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) Severity Score Between Baseline and the Average of Week 15 Through Week 26
The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Average baseline morning ItchRO (Obs) scores were calculated as sum of the morning scores divided by number of morning scores for the 4-week (28 days) time periods (that is [i.e.], Day -28 to Day -1). Average morning ItchRO (Obs) scores Week 15 through Week 26 were calculated as the sum of the morning scores divided by the number of morning scores from Week 15 to Week 26. Change was calculated as: Average value of Weeks 15 to 26 - Average value of Baseline (Day -28 to Day -1).
Measured: Baseline to Week 15 through Week 26

Secondary outcomes (4)

Change in the Average Morning ItchRO (Obs) Frequency Score Between Baseline and the Average of Week 15 Through Week 26
The ItchRO (Obs) scale measures frequency of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1= A little bit of the time, 2= Some of the time, 3= Most of the time, 4= Almost all of the time/constantly, I don't know) to describe their pruritus condition. 'I don't know' was categorized as missing data. A higher score indicated more severe pruritus. Baseline average morning ItchRO (Obs) frequency scores were calculated as the sum of the morning frequency scores divided by the number of morning severity scores for the 4-week (28 days) time periods. (i.e., Day -28 to Day -1). Average morning ItchRO (Obs) frequency scores of Week 15 through Week 26 were calculated as the sum of the morning frequency scores divided by the number of mornings frequency scores from Week 15 to Week 26. Change was calculated as: Average value of Weeks 15 to 26 - Average value of Baseline (Day -28 to Day -1).
Measured: Baseline to Week 15 through Week 26
Change From Baseline in Total Serum Bile Acid (sBA) Levels to Week 26
Change from baseline was calculated as: Post-baseline observed value - Baseline (before first dosing) observed value. Change from baseline in total sBA levels to Week 26 was reported.
Measured: Baseline to Week 26
Percentage of Participants (Responders) Who Experienced an sBA Control From Baseline Through Week 26
Responders to sBA control were defined as participants who achieved a decrease to less than (<) 102 mcmol/L, a decrease of greater than (>) 75 percentage (%), or normalization at any timepoint from baseline through Week 26.
Measured: Baseline through Week 26
Change in the ItchRO (Obs) Weekly Average Severity Between Baseline and the Average of Week 15 Through Week 26
ItchRO (Obs) scale measures severity of pruritus, score ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average severity was calculated based on daily maximum severity scores from both morning and evening. Average baseline morning and evening ItchRO (Obs) scores were calculated as sum of morning or evening scores divided by number of morning or evening scores for 4-week (28 days) time periods (i.e., Day -28 to Day -1). Average morning and evening ItchRO (Obs) scores Week 15 to Week 26 were calculated as sum of morning or evening scores divided by number of morning or evening scores from Week 15 to Week 26. Change was calculated as: Average value of Weeks 15 to 26 - Average value of Baseline (Day -28 to Day -1).
Measured: Baseline to Week 15 through Week 26

Timeline

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

10 Jan 202322 Jul 2025

First posted16 Sep 2022
Study start10 Jan 2023
Primary completion4 Sep 2023
Study completion22 Jul 2025

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.
Other trials for Progressive Familial Intrahepatic Cholestasis (PFIC)Studies of the same condition, open and under way.
More trials run by TakedaThe 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05543187
Sponsor's protocol ID: TAK-625-3002
Other IDs: jRCT2031220356
Status last verified: Jan 2026
First submitted: 14 Sep 2022
Last updated: 28 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).

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

RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China
Progressive Familial Intrahepatic Cholestasis
Active, not recruitingObservational study
Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
PFIC - Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
Pediatric Evaluation and Registry for Liver Cholestasis in Canada
PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS)

All Progressive Familial Intrahepatic Cholestasis (PFIC) trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of TAK-625 in the Treatment of Subjects With Progressive Familial Intrahepatic Cholestasis
ClinicalTrials.gov ID: NCT05543187
Acronym / sponsor ID: TAK-625-3002
Conditions: Progressive Familial Intrahepatic Cholestasis (PFIC)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 10 Jan 2023 (actual)
Primary completion: 4 Sep 2023 (actual)
Study completion: 22 Jul 2025 (actual)
First posted: 16 Sep 2022 (actual)
Results: Posted 24 Sep 2024

Clinical summary

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

The participants will be treated with TAK-625 for up to the end of study (about 34 months).

Participants will visit their study clinic 15 times from the start of study. After 15 times visits, participants will visit their study clinic every 12 weeks up to the end of study.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TAK-625, Primary cohort	Experimental	Drug: TAK-625TAK-625 orally, twice daily (BID) for 4 weeks as Dose Escalation Period. The dose in Dose Escalation Period will be increased weekly, 150 mcg/kilograms (kg), 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg. After Dose Escalation Period, TAK-625 600 mcg/kg (or maximum tolerated dose [MTD]), orally, BID up to study completion.
TAK-625, Supplemental cohort	Experimental	Drug: TAK-625TAK-625 orally, twice daily (BID) for 4 weeks as Dose Escalation Period. The dose in Dose Escalation Period will be increased weekly, 150 mcg/kilograms (kg), 300 mcg/kg, 450 mcg/kg, and 600 mcg/kg. After Dose Escalation Period, TAK-625 600 mcg/kg (or maximum tolerated dose [MTD]), orally, BID up to study completion.

Who may qualify

Ages: 1 month and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (16 listed)

The participant is Japanese male or female with a body weight >=3.0 kg and who is >=1 month of age at the time of informed consent.
The participant has a cholestasis as manifested by total serum bile acid (sBA) >=3^ upper limit of the normal range (ULN) (applies to the primary cohort only).
The participant has an average morning ItchRO (Obs) score >=1.5 during 4 consecutive weeks of the screening period, leading to the baseline visit (Week 0/Visit 2). Since it is difficult to evaluate pruritus in infants, participants <12 months of age at screening whose pruritus is unavoidably difficult to be evaluated are not necessarily required to meet the above score.
The caregiver has completed at least 21 valid* morning ItchRO (Obs) entries during 4 consecutive weeks of the screening period, leading to the baseline visit (Week 0/Visit 2) (*valid=completed and not answered as "I don't know"; the maximum allowed invalidreports=7, no more than 2 invalid reports during the last 7 days before the baseline visit [Week 0/Visit 2]).
The participant has a diagnosis of progressive familial intrahepatic cholestasis (PFIC) based on:

Key exclusion criteria (13 listed)

The diagnosed with PFIC2 due to ABCB11 mutation that predicts complete absence of BSEP function due to the type of ABCB11 mutation (t-PFIC2), based on a genotyping (applies to the primary cohort only).
The participant has a diagnosis of benign recurrent intrahepatic cholestasis indicated by a history of intermittent cholestasis with no disease progression.
The participant has a current or recent history (<1 year) of atopic dermatitis or other non-cholestatic diseases associated with pruritus.
The participant has a previous history of surgical interruption of the enterohepatic circulation (applies to the primary cohort only).
The participant with chronic diarrhea requiring intravenous (IV) fluid or nutritional intervention and/or its sequelae at screening or during the 6 months prior to screening.

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
TAK-625Also: Maralixibat chlorideTAK-625 orally, twice daily (BID)	Drug	TAK-625, Primary cohort, TAK-625, Supplemental cohort

Primary outcome

Change in the Average Morning Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) Severity Score Between Baseline and the Average of Week 15 Through Week 26
Time frame: Baseline to Week 15 through Week 26
The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Average baseline morning ItchRO (Obs) scores were calculated as sum of the morning scores divided by number of morning scores for the 4-week (28 days) time periods (that is [i.e.], Day -28 to Day -1). Average morning ItchRO (Obs) scores Week 15 through Week 26 were calculated as the sum of the morning scores divided by the number of morning scores from Week 15 to Week 26. Change was calculated as: Average value of Weeks 15 to 26 - Average value of Baseline (Day -28 to Day -1).

4 secondary outcomes

Change in the Average Morning ItchRO (Obs) Frequency Score Between Baseline and the Average of Week 15 Through Week 26
Time frame: Baseline to Week 15 through Week 26
Change From Baseline in Total Serum Bile Acid (sBA) Levels to Week 26
Time frame: Baseline to Week 26
Percentage of Participants (Responders) Who Experienced an sBA Control From Baseline Through Week 26
Time frame: Baseline through Week 26
Change in the ItchRO (Obs) Weekly Average Severity Between Baseline and the Average of Week 15 Through Week 26
Time frame: Baseline to Week 15 through Week 26

Results and safety

Results posted to the registry on 24 Sep 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
Primary Cohort: TAK-625	3	3
Supplemental Cohort: TAK-625	2	2

Primary outcome: Change in the Average Morning Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) Severity Score Between Baseline and the Average of Week 15 Through Week 26

Time frame: Baseline to Week 15 through Week 26. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Primary Cohort: TAK-625 n = 3	Supplemental Cohort: TAK-625 n = 2
Value	-1.514 (-3.6541 to 0.6255)	-0.202 (-3.6957 to 3.2911)

Population analysed: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the cohort-wise (primary and supplemental) data were analyzed, collected, and reported in this study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study drug administration up to follow-up (up to Week 133). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Cohort: TAK-625	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Supplemental Cohort: TAK-625	0 of 2 (0%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).

Related trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China
Progressive Familial Intrahepatic Cholestasis
Active, not recruitingObservational study
Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)
PFIC - Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
RecruitingObservational study
Pediatric Evaluation and Registry for Liver Cholestasis in Canada
PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS)

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.

Study Director study director

Takeda

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-625 in people with Progressive Familial Intrahepatic Cholestasis (PFIC), run by Takeda at 8 sites in Japan.

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 16 inclusion and 13 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. 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 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 24 Sep 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?

Change in the Average Morning Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) Severity Score Between Baseline and the Average of Week 15 Through Week 26 (time frame: Baseline to Week 15 through Week 26). 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 NCT05543187.

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 28 Jan 2026.