Primary Biliary Cholangitis (PBC)Phase 1/2NCT07304843
A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction
A Phase 1/2 study testing golexanolone in people with Primary Biliary Cholangitis (PBC), run by Umecrine Cognition AB at 38 sites in 8 countries.
Trial summary
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone compared with placebo among subjects with a history of non-cirrhotic or Child-Pugh class A… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- What is being tested?
- golexanolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 38 sitesin 8 countries
- Study dates
- 14 Apr 2023to 9 Sep 2026
- Phase
- Phase 1/2
- 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 and female subjects age ≥ 18 years
- Diagnosis of PBC based on the presence of ≥2 of 3 key disease characteristics
- Clinically significant fatigue defined for the purposes of this study as a PBC-40 fatigue domain score of ≥29 at screening
- Clinically significant cognitive symptoms, defined for the purposes of this study as a PBC-40 cognitive domain ≥16 at screening
- Stable PBC SoC therapy (if any),for at least 3 months prior to randomisation
- For all women of childbearing potential (WOCBP) a negative pregnancy test at screening and a negative urine dip-stick pregnancy test at baseline, prior to first dose of IMP
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- WOCBP must be willing to use a contraceptive method with a failure rate of < 1% and agree to continue use of this method for the duration of the study and thereafter for 1 month after the last dosing of the IMP
- Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal
- Fertile male subjects must be willing to use condom and assure that their female partner will use contraceptive methods with a failure rate of < 1%
- Willing and able to give informed consent
- The subject should be judged by the Investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent
Who cannot join
- Child-Pugh class B or C cirrhosis
- Clinical evidence of hepatic decompensation (e.g. current or prior HE, ascites, or variceal bleeding)
- History of hepatocellular carcinoma
- Bilirubin >1.5 x ULN
- Glomerular filtration rate (GFR) <35 mL/min/1.73m2
- Low Haemoglobin (HB), i.e. subjects with moderate/severe anaemia
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- Low S-B12 or low P-folate
- Evidence of biliary obstruction
- Any positive result on screening for human immunodeficiency virus (HIV), or hepatitis B (serum hepatitis B surface antigen positive)
- Prolonged QTcF (>500 ms), or any clinically significant abnormality in the resting ECG, as judged by the Investigator (at screening)
- Concomitant disease characterised by chronic fatigue and/or cognitive impairment
- Clinically significant bowel disease, including obstruction, active inflammatory bowel disease, or malabsorption
- Clinically significant sleep apnoea
- An uncontrolled thyroid disorder
- Subjects with a history of or currently active immune disorders (i.e. uncontrolled) other that PBC (including autoimmune disease) and/or diseases requiring immunosuppressive drugs
- Clinical diagnosis of autoimmune hepatitis overlap
- The presence, as judged by the Investigator, of clinically significant concomitant illness which would jeopardise safe participation in the study and /or the interpretation of study findings
- Regular use of prescribed or over the counter (OTC) medications known to cause fatigue or cognitive dysfunction
- Use of prohibited medications within 14 days prior to randomisation
- Anticipated change in PBC medication and/or significant medical or surgical intervention within the duration of the study
- Regular (more than 1 week per month) alcohol consumption in excess of 14 units per week
- Administration of another new chemical entity or has participated in any other clinical study that included drug treatment with the last administration within 3 months prior to administration of IMP in this study
- Females who are pregnant, nursing or actively trying to conceive a child
- Expected inability to swallow the required number of IMP capsules at the applicable dose level
- History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator
Trial locations and contacts
38 sites in 8 countries.
38 sites in 8 countries
Spain9 sites
Hospital Universitario Parc Taulí
Barcelona, 08208
Hospital Clinic Barcelona
Barcelona, 8036
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital 12th October, Madrid
Madrid, 28041
Hospital Universitario Virgen De La Victoria
Málaga, 29010
University Hospital Complex of Pontevedra & IIS Galicia South, Pontevedra
Pontevedra, 36071
University Hospital Marquez de Valdecilla, Santander
Santander, 39008
Virgen del Rocio University Hospital
Seville, 41013
Hospital Universitario y Politécnico La Fe
Valencia, 46026
United Kingdom9 sites
NIHR Birmingham BRC
Birmingham, B15 2TT
Glasgow Royal Infirmary
Glasgow, G4 0SF
Royal Free London NHS Foundation Trust
London, NW3 2QG
Guy's and St Thomas' Hospital, London
London, SE1 7EH
Freeman Hospital
Newcastle, NE7 7DN
Nottingham Digestive Diseases Centre and Biomedical Research Centre Nottingham University Hospitals NHS Trust, Queen's Medical Centre
Nottingham, NG7 2UH
Oxford University Hospitals NHS Foundation Trust
Oxford
Dept of Gastroenterology & Hepatology Portsmouth Hospitals University NHS Trust Queen Alexandra Hospital
Portsmouth, PO6 3LY
Royal Wolverhampton NHS Trust, New Cross Hospital
Wolverhampton, WV10 0QP
Turkey (Türkiye)8 sites
Hacettepe University, Fakulty of Medicine, Department of Gastroenterology and Hepatology
Ankara, 06230
9 Eylul University Research and Application Hospital Department of Gastroenterology
Balçova, 35340
Dicle University Faculty of Medicine Department of Gastroenterology
Diyarbakır, 21280
Ege University Faculty of Medicine, Department of Gastroenterology
Izmir, 35100
Kocaeli University Faculty of Medicine Gastroenterology and Hepatology Department
Kocaeli, 41100
Recep Tayyip Erdoğan University Training and Research Hospital, Department of Gastroenterology
Rize, 53020
Harran Üniversitesi Osmanbey Campus Department of Gastroenterology
Sanliurfa, 63300
Karadeniz Technical University, Farabi Hospital, Department of Gastroenterology
Trabzon, 61080
Italy6 sites
Università di Milano-Bicocca, S.C. ASST Grande Ospedale Metropolitano Niguarda, Dipartimento di Medicina e Chirurgia, Epatologia e Gastroenterologia
Milan, 20162
University of Padova, Department of Surgery, Oncology and Gastroenterology
Padova, 35128
University Hospital Paolo Giaccone, University of Palermo
Palermo, 90127
A. Gemelli Polyclinic, Sacro Cuore Catholic University
Roma, 168
Humanitas University
Rozzano, 20089
University of Udine
Udine, 33100
Germany2 sites
University Hospital Düsseldorf
Düsseldorf, 40225
University of Leipzig
Leipzig, 04103
Greece2 sites
Hippokration General Hospital of Athens
Athens, 11527
University Hospital of Patras
Pátrai, 26504
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Two-part Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Preliminary Efficacy of Two Dose Levels of Golexanolone in Subjects With Primary Biliary Cholangitis (PBC), Fatigue, and Cognitive Dysfunction
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone compared with placebo among subjects with a history of non-cirrhotic or Child-Pugh class A cirrhotic Primary Biliary Cholangitis (PBC) with clinically significant fatigue and cognitive symptoms on stable background standard of care (SoC) PBC medication. The objectives of this research study are to assess the safety and tolerability as well the pharmacokinetic (PK) characteristics of golexanolone administered 40 mg BID for 5 days in the target population (part A) and to assess the safety and tolerability, the effects of golexanolone on health-related quality of life (HRQoL), including fatigue, day-time sleepiness and cognitive function as well as Investigator's overall impression of treatment effect of 28 days twice per day (BID) treatment with two dose levels of golexanolone versus placebo (part B).
- Conditions
- Primary Biliary Cholangitis (PBC)
- Being tested
- golexanolone, Placebo
- Keywords
- PBC, Cognition, Fatigue
- Medical subject headings
- Liver Cirrhosis, Biliary, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
golexanoloneDrug
soft gelatin capsules, oral dosage twice per day for up to 28 days
golexanoloneDrug
soft gelatin capsules, oral dosage twice a day for up to 28 days
PlaceboDrug
soft gelatin capsules, oral dosage twice a day for up to 28 days
golexanoloneDrug
soft gelatin capsules, oral dosage twice per day for 5 days
PlaceboDrug
soft gelatin capsules, oral dosage twice per day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Part B: Treatment arm 1 (golexanolone 40 mg) | Experimental | 40 mg golexanolone BID Receives: Drug: golexanolone |
| Part B: Treatment arm 2 (golexanolone 80 mg) | Experimental | 80 mg golexanolone BID Receives: Drug: golexanolone |
| Placebo | Placebo comparator | Part B: Placebo BID Receives: Drug: Placebo |
| Part A: Golexanolone | Experimental | 40 mg golexanolone BID Receives: Drug: golexanolone |
| Part A: Placebo | Placebo comparator | Placebo BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 28 (part B)
Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 28
Measured: From enrollment to the end of treatment at 28 days
Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 5 (part A)
Frequency, intensity, and seriousness of adverse events (AEs)
Measured: From Baseline to Day 5
Secondary outcomes (8)
1. Change from baseline to Day 28 in PBC-40 scores for each of the domains (cognition, itch, fatigue, social, emotional, and general symptoms) (part B)
The PBC-40 is a patient-derived, disease specific health-related quality of life measure for PBC. The paper questionnaire consists of 40 questions, each scored on a scale of 1 to 5 (where 1=least impact, 5=greatest impact) grouped into six domains (cognition, itch, fatigue, social, emotional, and general symptoms). For each domain, scoring involves summing individual question response scores, range of 6-30. Higher scores indicate a poorer quality of life
Measured: From baseline to Day 28
2. Change from baseline to Day 28 in EQ-5D-3L tool (part B)
The EQ-5D tool is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal.
Measured: From baseline to Day 28
3. Change from baseline to Day 28 in daytime sleepiness related symptoms using the Epworth Sleepiness Scale (ESS) (part B)
ESS is a validated self-administered questionnaire for assessment of daytime hypersomnolence. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of eight item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.
Measured: From baseline to Day 28
4. Change from baseline to Day 28 in Portosystemic Hepatic Encephalopathy Score (PHES) total score (part B)
The PHES is composed of five sub-tests, number connection test-A (NCT-A), number connection test-B (NCT-B), serial dotting test (SDT), line tracing test (LTT) and digit symbol test (DST). PHES assesses motor speed, motor accuracy, concentration, attention, visual perception, visual-spatial orientation, visual construction, and memory.
Measured: From baseline to Day 28
5. Change from baseline to Day 28 in Rey Auditory Verbal Learning test (RAVLT) (part B)
The RAVLT is a validated word list learning task composed of 15 words that are read to the subject at a rate of one word/second after which the subject is asked to recall as many words as they can. This procedure is repeated five times. The sum of words recalled across these five trials constitutes the immediate recall score.
Measured: From baseline to Day 28
6. Change from baseline to Day 28 in Delis and Kaplan Executive Function System (D-KEFS) Letter and Category fluency subtests (part B)
The Category Fluency and Letter Fluency tests from the D-KEFS are validated ideational fluency tasks in which the subject is asked to say as many words as possible in 1 minute that adhere to a particular rule.
Measured: From baseline to Day 28
7. To evaluate the Investigator's overall impression of treatment effect by Clinical Global Impression of change, PBC version (CGI-C-PBC) from baseline to Day 28 (part B)
The clinical global impression (CGI) scale consists of two clinician-rated instruments, CGI-S-PBC and CGI-C-PBC, respectively measuring overall disease severity and change. The CGI-S-PBC entails a 30-45 minute semi-structured interview examining all six clinical domains identified as clinically relevant for patients living with PBC. Domain-specific and global ratings are rendered by trained independent clinical raters who are experts in PBC and have been certified for this purpose to be central raters. All CGI-S-PBC and CGI-C-PBC interviews will be video-recorded and used to support the evaluation made by the raters.
Measured: From baseline to Day 28
8. To assess the exposure of two dose levels of golexanolone in the target population treated for 28 days (part B)
The lowest plasma concentration before the next dose (Ctrough) will be assessed pre-dose on Days 1, 14, and 28
Measured: At Day 1, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start14 Apr 2023
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A (phase 1b) includes 6 subjects on active (40 mg BID for five days) and 2 subjects on placebo (BID for five days) Part B (phase 2a) includes 3 arms (40 mg BID, 80 mg BID or placebo for 28 days)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umecrine Cognition AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pernilla Sandwall, Study director, Umecrine Cognition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304843
- Sponsor's protocol ID
- UCAB-CT-05
- Other IDs
- 2024-515907-20-00, IRAS ID 1003871, 515-04-27580-22-1, E-66175679-514.02.02-1264666
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Two-part Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Preliminary Efficacy of Two Dose Levels of Golexanolone in Subjects With Primary Biliary Cholangitis (PBC), Fatigue, and Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT07304843
- Acronym / sponsor ID
- UCAB-CT-05
- Conditions
- Primary Biliary Cholangitis (PBC)
- Keywords
- PBC, Cognition, Fatigue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Umecrine Cognition ABIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 26 Dec 2025 (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.
The present phase 1b/2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone compared with placebo among subjects with a history of non-cirrhotic or Child-Pugh class A cirrhotic Primary Biliary Cholangitis (PBC) with clinically significant fatigue and cognitive symptoms on stable background standard of care (SoC) PBC medication. The objectives of this research study are to assess the safety and tolerability as well the pharmacokinetic (PK) characteristics of golexanolone administered 40 mg BID for 5 days in the target population (part A) and to assess the safety and tolerability, the effects of golexanolone on health-related quality of life (HRQoL), including fatigue, day-time sleepiness and cognitive function as well as Investigator's overall impression of treatment effect of 28 days twice per day (BID) treatment with two dose levels of golexanolone versus placebo (part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Part A (phase 1b) includes 6 subjects on active (40 mg BID for five days) and 2 subjects on placebo (BID for five days) Part B (phase 2a) includes 3 arms (40 mg BID, 80 mg BID or placebo for 28 days)
| Arm | Type | Receives |
|---|---|---|
| Part B: Treatment arm 1 (golexanolone 40 mg) | Experimental | Drug: golexanolone40 mg golexanolone BID |
| Part B: Treatment arm 2 (golexanolone 80 mg) | Experimental | Drug: golexanolone80 mg golexanolone BID |
| Placebo | Placebo comparator | Drug: PlaceboPart B: Placebo BID |
| Part A: Golexanolone | Experimental | Drug: golexanolone40 mg golexanolone BID |
| Part A: Placebo | Placebo comparator | Drug: PlaceboPlacebo BID |
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 and female subjects age ≥ 18 years
- Diagnosis of PBC based on the presence of ≥2 of 3 key disease characteristics
- Clinically significant fatigue defined for the purposes of this study as a PBC-40 fatigue domain score of ≥29 at screening
- Clinically significant cognitive symptoms, defined for the purposes of this study as a PBC-40 cognitive domain ≥16 at screening
- Stable PBC SoC therapy (if any),for at least 3 months prior to randomisation
Key exclusion criteria (25 listed)
- Child-Pugh class B or C cirrhosis
- Clinical evidence of hepatic decompensation (e.g. current or prior HE, ascites, or variceal bleeding)
- History of hepatocellular carcinoma
- Bilirubin >1.5 x ULN
- Glomerular filtration rate (GFR) <35 mL/min/1.73m2
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 |
|---|---|---|
| golexanolonesoft gelatin capsules, oral dosage twice per day for up to 28 days | Drug | Part B: Treatment arm 1 (golexanolone 40 mg) |
| golexanolonesoft gelatin capsules, oral dosage twice a day for up to 28 days | Drug | Part B: Treatment arm 2 (golexanolone 80 mg) |
| Placebosoft gelatin capsules, oral dosage twice a day for up to 28 days | Drug | Placebo |
| golexanolonesoft gelatin capsules, oral dosage twice per day for 5 days | Drug | Part A: Golexanolone |
| Placebosoft gelatin capsules, oral dosage twice per day for 5 days | Drug | Part A: Placebo |
Primary outcome
1. Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 28 (part B)
Time frame: From enrollment to the end of treatment at 28 days
Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 28
Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 5 (part A)
Time frame: From Baseline to Day 5
Frequency, intensity, and seriousness of adverse events (AEs)
8 secondary outcomes
1. Change from baseline to Day 28 in PBC-40 scores for each of the domains (cognition, itch, fatigue, social, emotional, and general symptoms) (part B)
Time frame: From baseline to Day 28
2. Change from baseline to Day 28 in EQ-5D-3L tool (part B)
Time frame: From baseline to Day 28
3. Change from baseline to Day 28 in daytime sleepiness related symptoms using the Epworth Sleepiness Scale (ESS) (part B)
Time frame: From baseline to Day 28
4. Change from baseline to Day 28 in Portosystemic Hepatic Encephalopathy Score (PHES) total score (part B)
Time frame: From baseline to Day 28
5. Change from baseline to Day 28 in Rey Auditory Verbal Learning test (RAVLT) (part B)
Time frame: From baseline to Day 28
6. Change from baseline to Day 28 in Delis and Kaplan Executive Function System (D-KEFS) Letter and Category fluency subtests (part B)
Time frame: From baseline to Day 28
7. To evaluate the Investigator's overall impression of treatment effect by Clinical Global Impression of change, PBC version (CGI-C-PBC) from baseline to Day 28 (part B)
Time frame: From baseline to Day 28
8. To assess the exposure of two dose levels of golexanolone in the target population treated for 28 days (part B)
Time frame: At Day 1, 14 and 28
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernilla Sandwall study director
Umecrine Cognition
38 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing golexanolone in people with Primary Biliary Cholangitis (PBC), run by Umecrine Cognition AB at 38 sites in 8 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 11 inclusion and 25 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Spain, United Kingdom, Turkey (Türkiye), Italy, Germany and 3 more countries. 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 combined 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.
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 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?
1. Frequency, intensity, and seriousness of adverse events (AEs) from baseline to Day 28 (part B) (time frame: From enrollment to the end of treatment at 28 days). 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?
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 16 Oct 2026.