Tenosynovial Giant Cell TumorPhase 3MOTIONNCT05059262
Study of Vimseltinib for Tenosynovial Giant Cell Tumor
A Phase 3 study testing Vimseltinib in people with Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, run by Deciphera Pharmaceuticals, LLC at 35 sites in 13 countries.
Trial summary
This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath
- What is being tested?
- Vimseltinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 35 sitesin 13 countries
- Study dates
- 14 Oct 2021to Jul 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age
- TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
- Symptomatic disease as defined as at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period and documented in the medical record
- Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol
- Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug
- Must have measurable disease, as per RECIST Version 1.1, with at least one lesion having a minimum size of 2cm
Show all 10Show fewer
- Adequate organ and bone marrow function
- If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements
- Must provide signed consent to participate in the study and is willing to comply with study-specific procedures
- Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device
Who cannot join
- Previous use of systemic therapy (investigational or approved) targeting colony-stimulating factor 1 (CSF1) or colony-stimulating factor 1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed
- Received therapy for TGCT, including investigational therapy during the screening period. Participated in a non-TGCT investigational drug study within 30 days of screening.
- Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis)
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome
- Concurrent treatment with any study-prohibited medications
- Major surgery within 14 days of the first dose of study drug
Show all 13Show fewer
- Any clinically significant comorbidities
- Active liver or biliary disease including nonalcoholic steatohepatitis (NASH) or cirrhosis
- Malabsorption syndrome or other illness that could affect oral absorption
- Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis infection
- If female, the participant is pregnant or breastfeeding
- Known allergy or hypersensitivity to any component of the study drug
- Contraindication to MRI
Trial locations and contacts
35 sites in 13 countries.
35 sites in 13 countries
United States11 sites
University of Colorado
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Ohio State University
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Duke Sarcoma Research
Durham, North Carolina, 27710
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Kansas
Kansas City, Kansas, 66160
Memorial Sloan-Kettering Cancer Center
New York, New York, 10016
Mayo Clinic Rochester
Rochester, Minnesota, 55902
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Italy5 sites
Istituto Ortopedico Rizzoli
Bologna
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples
Istituto Oncologico Veneto
Padua
Istituto Nazionale Tumori Regina Elena
Rome
Spain4 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Fundacion Jimenez Diaz
Madrid
Hospital Clinico San Carlos
Madrid
France3 sites
Institut Bergonié
Bordeaux
Centre Léon Bérard
Lyon
Institut Gustave Roussy
Villejuif
Germany2 sites
Helios Klinikum Berlin-Buch
Berlin
University Hospital Essen (Universitätsklinikum Essen)
Essen
United Kingdom2 sites
Cancer & Haematology Centre, The Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
London
University College London Hospitals
London
Poland1 site
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw
About this study
Official title: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)
This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option.
The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.
- Conditions
- Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Localized
- Being tested
- Vimseltinib, Placebo
- Keywords
- TGCT, PVNS
- Medical subject headings
- Giant Cell Tumor of Tendon Sheath, Synovitis, Pigmented Villonodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VimseltinibDrug
Also called DCC-3014
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1/Part 2 - Vimseltinib/Vimseltinib | Experimental | Participants received blinded treatment of 30 mg twice a week (BIW) vimseltinib for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2. Receives: Drug: Vimseltinib |
| Part 1/Part 2: Placebo/Vimseltinib | Placebo comparator | Participants received blinded treatment of BIW matching placebo for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2. Receives: Drug: Vimseltinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR).
- CR: Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in short axis. Non-nodal targets must be absent.
- PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Baseline to Week 25 (Cycle 7, Day 1)
Secondary outcomes (6)
ORR at Week 25 Per Tumor Volume Score (TVS)
TVS is a semi-quantitative magnetic resonance imaging (MRI) scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. ORR was the percentage of participants who achieved either CR or PR as assessed by blinded IRR using TVS.
- CR: Lesion completely gone
- PR: ≥50% decrease in volume score relative to Baseline.
Measured: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in Active Range of Motion (ROM) at Week 25
Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard).
Measured: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25
All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes.
Measured: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25
The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness.
Measured: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25
The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state.
Measured: Baseline to Week 25 (Cycle 7, Day 1)
Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use
Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who:
(i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use.
Measured: Baseline to Week 25 (Cycle 7, Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start14 Oct 2021
- Primary completion10 Aug 2023
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tenosynovial Giant Cell TumorStudies of the same condition, open and under way.
- More trials run by Deciphera Pharmaceuticals, LLCThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deciphera Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059262
- Sponsor's protocol ID
- DCC-3014-03-001
- Other IDs
- 2024-513624-42-00
- Acronym
- MOTION
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2021
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, Lopez Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martin-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herraez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. doi: 10.1016/S0140-6736(24)00885-7. Epub 2024 Jun 3.
PubMed 38843860Tap WD, Sharma MG, Vallee M, Smith BD, Sherman ML, Ruiz-Soto R, de Sande MV, Randall RL, Bernthal NM, Gelderblom H. The MOTION study: a randomized, phase III study of vimseltinib for the treatment of tenosynovial giant cell tumor. Future Oncol. 2024 Mar;20(10):593-601. doi: 10.2217/fon-2023-0238. Epub 2023 Aug 18.
PubMed 37593881
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)
- ClinicalTrials.gov ID
- NCT05059262
- Acronym / sponsor ID
- MOTION / DCC-3014-03-001
- Conditions
- Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Localized
- Keywords
- TGCT, PVNS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Deciphera Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option.
The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1/Part 2 - Vimseltinib/Vimseltinib | Experimental | Drug: VimseltinibParticipants received blinded treatment of 30 mg twice a week (BIW) vimseltinib for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2. |
| Part 1/Part 2: Placebo/Vimseltinib | Placebo comparator | Drug: Vimseltinib, Drug: PlaceboParticipants received blinded treatment of BIW matching placebo for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients ≥18 years of age
- TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
- Symptomatic disease as defined as at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period and documented in the medical record
- Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol
- Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug
Key exclusion criteria (13 listed)
- Previous use of systemic therapy (investigational or approved) targeting colony-stimulating factor 1 (CSF1) or colony-stimulating factor 1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed
- Received therapy for TGCT, including investigational therapy during the screening period. Participated in a non-TGCT investigational drug study within 30 days of screening.
- Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis)
- QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome
- Concurrent treatment with any study-prohibited medications
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 |
|---|---|---|
| VimseltinibAlso: DCC-3014Administered orally | Drug | Part 1/Part 2 - Vimseltinib/Vimseltinib, Part 1/Part 2: Placebo/Vimseltinib |
| PlaceboAdministered orally | Drug | Part 1/Part 2: Placebo/Vimseltinib |
Primary outcome
Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR). * CR: Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in short axis. Non-nodal targets must be absent. * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
6 secondary outcomes
ORR at Week 25 Per Tumor Volume Score (TVS)
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in Active Range of Motion (ROM) at Week 25
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use
Time frame: Baseline to Week 25 (Cycle 7, Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38843860Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, Lopez Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martin-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herraez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. doi: 10.1016/S0140-6736(24)00885-7. Epub 2024 Jun 3.
- Derived from this study: PubMed 37593881Tap WD, Sharma MG, Vallee M, Smith BD, Sherman ML, Ruiz-Soto R, de Sande MV, Randall RL, Bernthal NM, Gelderblom H. The MOTION study: a randomized, phase III study of vimseltinib for the treatment of tenosynovial giant cell tumor. Future Oncol. 2024 Mar;20(10):593-601. doi: 10.2217/fon-2023-0238. Epub 2023 Aug 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vimseltinib in people with Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, run by Deciphera Pharmaceuticals, LLC at 35 sites in 13 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 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Italy, Spain, France, Canada and 8 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 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 Feb 2025). 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?
Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (time frame: Baseline to Week 25 (Cycle 7, Day 1)). 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 NCT05059262, which also lists 2 linked publications.
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 20 Mar 2026.