PsoriasisPhase 2NCT05044234
A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis
A Phase 2 study testing Cedirogant in people with Psoriasis, run by AbbVie at 53 sites in 3 countries.
Trial summary
Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Cedirogant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 53 sitesin 3 countries
- Study dates
- 16 Nov 2021to 30 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
Who cannot join
- Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
- Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.
Trial locations and contacts
53 sites in 3 countries.
53 sites in 3 countries
United States37 sites
Arlington Research Center, Inc /ID# 244171
Arlington, Texas, 76011
Orion Clinical Research /ID# 238619
Austin, Texas, 78759-4100
Bellaire Dermatology Associates /ID# 247865
Bellaire, Texas, 77401
UAB Department of Dermatology /ID# 238563
Birmingham, Alabama, 35233
Clinical Research Center of the Carolinas /ID# 238827
Charleston, South Carolina, 29407
Darst Dermatology /ID# 238677
Charlotte, North Carolina, 28277
Univ Hosp Cleveland /ID# 245953
Cleveland, Ohio, 44106
Cleaver Medical Group Dermatology - Dawsonville /ID# 246327
Dawsonville, Georgia, 30534-6369
Zel Skin & Laser Specialists - Edina /ID# 238714
Edina, Minnesota, 55424-1200
Encino Research Center /ID# 245950
Encino, California, 91436
Center for Clinical Studies - Houston (Binz) /ID# 243700
Houston, Texas, 77004-8097
Dawes Fretzin, LLC /ID# 238704
Indianapolis, Indiana, 46256
Clinical Partners, LLC /ID# 238620
Johnston, Rhode Island, 02919
Forest Hills Dermatology Group /ID# 238708
Kew Gardens, New York, 11415
Marietta Dermatology Clinical Research /ID# 238679
Marietta, Georgia, 30060-1047
Dermatologists of Southwest Ohio, Inc /ID# 238939
Mason, Ohio, 45040-4520
Lakes Research, LLC /ID# 238831
Miami, Florida, 33014
Florida International Rsrch cr /ID# 245959
Miami, Florida, 33173
West Virginia Research /ID# 238517
Morgantown, West Virginia, 26505-0589
Tennessee Clinical Research Center /ID# 238682
Nashville, Tennessee, 37215-2885
Velocity Clinical Research, Inc. /ID# 239536
North Hollywood, California, 91606
Arkansas Research Trials, LLC /ID# 238687
North Little Rock, Arkansas, 72117
Skin Specialists, PC /ID# 238514
Omaha, Nebraska, 68144
Medical Dermatology Specialist /ID# 238518
Phoenix, Arizona, 85006-2722
University of Pittsburgh MC /ID# 246170
Pittsburgh, Pennsylvania, 15260
Oregon Dermatology and Research Center /ID# 238823
Portland, Oregon, 97210
Health Concepts /ID# 238510
Rapid City, South Dakota, 57702
Arlington Dermatology /ID# 238701
Rolling Meadows, Illinois, 60008
Progressive Clinical Research /ID# 238565
San Antonio, Texas, 78229
Medderm Associates /ID# 238834
San Diego, California, 92103
Dermatology Specialists of Spokane /ID# 238809
Spokane, Washington, 99202
Lenus Research & Medical Group /ID# 238695
Sweetwater, Florida, 33172
Advanced Clinical Research Institute /ID# 238697
Tampa, Florida, 33607-6429
Clinical Research Trials of Florida, Inc. /ID# 238709
Tampa, Florida, 33607
ForCare Clinical Research /ID# 238856
Tampa, Florida, 33613-1244
Buffalo Medical Group /ID# 239068
Williamsville, New York, 14221
Wilmington Dermatology Center /ID# 246445
Wilmington, North Carolina, 28403
Japan10 sites
Hamamatsu University Hospital /ID# 239346
Hamamatsu, Shizuoka, 431-3192
Kansai Medical University Hospital /ID# 239278
Hirakata-shi, Osaka, 573-1191
The Jikei University Hospital /ID# 239319
Minato-ku, Tokyo, 105-8471
Nagoya City University Hospital /ID# 239286
Nagoya, Aichi-ken, 467-8602
Takagi Dermatology Clinic /ID# 239274
Obihiro-shi, Hokkaido, 080-0013
Okayama University Hospital /ID# 239285
Okayama, Okayama-ken, 700-8558
JR Sapporo Hospital /ID# 239277
Sapporo, Hokkaido, 060-0033
NTT Medical Center Tokyo /ID# 239287
Shinagawa-ku, Tokyo, 141-8625
Tokyo Medical University Hospital /ID# 239320
Shinjuku-ku, Tokyo, 160-0023
Mie University Hospital /ID# 239275
Tsu, Mie-ken, 514-8507
Canada6 sites
SimcoDerm Medical and Surgical Dermatology Center /ID# 238861
Barrie, Ontario, L4M 7G1
Dr. Wei Jing Loo Medicine Prof /ID# 238865
London, Ontario, N6H 5L5
Lynderm Research Inc. /ID# 243199
Markham, Ontario, L3P 1X2
Dr. Chih-ho Hong Medical Inc. /ID# 238864
Surrey, British Columbia, V3R 6A7
K. Papp Clinical Research /ID# 239695
Waterloo, Ontario, N2J 1C4
Wiseman Dermatology Research /ID# 238867
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis
Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis.
Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo.
Read more
Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.
There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.
- Conditions
- Psoriasis
- Being tested
- Cedirogant, Placebo
- Keywords
- Psoriasis, Plaque Psoriasis, Cedirogant, ABBV-157
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CedirogantDrug
Also called ABBV-157
Capsule, Oral
PlaceboDrug
Capsule, Oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. Receives: Drug: Placebo |
| 75 mg Cedirogant | Experimental | Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks. Receives: Drug: Cedirogant |
| 150 mg Cedirogant | Experimental | Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks. Receives: Drug: Cedirogant |
| 375 mg Cedirogant | Placebo comparator | Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks. Receives: Drug: Cedirogant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Measured: Baseline, Week 16
Secondary outcomes (6)
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
Measured: At Week 16
Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Measured: Baseline, Week 16
Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Measured: Baseline, Week 16
Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Measured: Baseline, Week 16
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline
The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms.
Measured: Baseline, Week 16
Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline
The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: "Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours?" The itch NRS scale scores vary between 0, representing "no itching" and 10, representing "worst itch imaginable."
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start16 Nov 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: Company Decision
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 PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044234
- Sponsor's protocol ID
- M18-816
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2021
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT05044234
- Acronym / sponsor ID
- M18-816
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Plaque Psoriasis, Cedirogant, ABBV-157
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis.
Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo.
Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks.
There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks. |
| 75 mg Cedirogant | Experimental | Drug: CedirogantParticipants received 75 mg cedirogant orally once daily (QD) for 16 weeks. |
| 150 mg Cedirogant | Experimental | Drug: CedirogantParticipants received 150 mg cedirogant orally once daily (QD) for 16 weeks. |
| 375 mg Cedirogant | Placebo comparator | Drug: CedirogantParticipants received 375 mg cedirogant orally once daily (QD) for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.
Key exclusion criteria (2 listed)
- Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
- Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.
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 |
|---|---|---|
| CedirogantAlso: ABBV-157Capsule, Oral | Drug | 150 mg Cedirogant, 375 mg Cedirogant, 75 mg Cedirogant |
| PlaceboCapsule, Oral | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16
Time frame: Baseline, Week 16
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
6 secondary outcomes
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
Time frame: At Week 16
Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16
Time frame: Baseline, Week 16
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline
Time frame: Baseline, Week 16
Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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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.
ABBVIE INC. study director
AbbVie
53 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cedirogant in people with Psoriasis, run by AbbVie at 53 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Japan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 29 Nov 2023). 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?
Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16 (time frame: Baseline, Week 16). 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 29 Nov 2023.