Trial · NCT07569081
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR (Objective response rate) at Week 26 | At Week 26 | ORR is defined as the proportion of participants who have achieved complete response (CR) or partial response (PR) during the 26-week Primary Treatment Period. |
| Secondary | Phase 2: Percentage of participants with partial response (PR) or complete response (CR) at Week 26 | At Week 26 | Percentage of participants with PR or CR at Week 26 to support identification of the Recommended Phase 3 dose (RP3D) |
| Secondary | Phase 2: Number of participants with adverse events and clinically significant changes in laboratory parameters, and vital signs to support identification of the RP3D | Up to 26 Weeks | |
| Secondary | Phase 2: Plasma concentrations of momelotinib and metabolite of momelotinib 21 (M21) to support identification of the RP3D | Up to 26 Weeks | |
| Secondary | Number of flare-free days | Up to 26 Weeks | Flare-free days are calendar days without clinical evidence of VEXAS flare and without treatment escalation. Total number of flare-free days is defined as the cumulative number of consecutive and non-consecutive flare-free days. |
| Secondary | Duration of response (DoR) | Up to 104 Weeks | DoR defined as the date of clinical response (CR or PR) to the date of relapse. |
| Secondary | Number of flare-free days with glucocorticoid (GC) dose <=10 mg/day | Up to 104 Weeks | Flare-free days are calendar days without clinical evidence of VEXAS flare and without treatment escalation. Total number of flare-free days is defined as the cumulative number of consecutive and non-consecutive flare-free days. |
| Secondary | Percentage of participants achieving complete and partial biochemical response | Up to 26 Weeks | Complete biological response is defined as complete or partial normalization of C-reactive protein. |
| Secondary | Objective response rate (ORR) at Week 52 | At Week 52 | ORR is defined as the proportion of participants who have achieved complete response or partial response |
| Secondary | Number of Participants with Hematologic Improvement- Erythroid (HI-E) response per International Working Group (IWG) 2018 criteria | Up to 26 Weeks | HI-E response is measured based on the combined incidence of: Low transfusion burden participants defined as absence of any transfusion for greater than or equal to (\>=)8 consecutive weeks. High transfusion burden participants: minor response defined as reduction by \>=50% of red blood cell (RBC) units for \>=8 consecutive weeks. Major response defined as absence of RBC transfusions for \>=8 consecutive weeks or longer up to 26 weeks. |
| Secondary | Change from Baseline in Short Form 36 (SF-36) domain and summary scores | Baseline and up to Week 48 | Short-Form 36 is a health-related survey that assesses quality of life covering 8 domains: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; and mental health. The domain scores are weighted to a scale ranging between 0 to 100, where higher score represents better health. The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are derived from the eight domain scores. These scores are standardized to a general U.S. population average of 50, with a standard deviation of 10. For both PCS and MCS, scores range from 0 to 100, higher scores indicate a better health outcome. |
| Secondary | Change from Baseline in European Organization for Research and Treatment of Cancer Item Library (EORTC IL) 479 score | Baseline and up to Week 156 | The EORTC Item Library is a database containing \>1000 individual items from more than 70 EORTC quality of life measures. A subset of 7 items from the library were selected based on symptoms experienced by participants with VEXAS syndrome. Scores range from 1 to 100 with higher scores representing a higher ("worse") level of symptoms. |
| Secondary | Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function Short Form 10b | Baseline and up to Week 156 | PROMIS Physical Function Short Form 10b consists of 10 questions; each with a 5-point response. PROMIS short form assesses self-reported capability of a participant rather than actual performance of physical activities. Higher scores indicate better functioning. Total possible range of scores is 10 to 50, with higher scores corresponding to a greater physical function ability. |
| Secondary | Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-FATIGUE) | Baseline and up to Week 156 | The FACIT-Fatigue is a short, 13-item questionnaire that assesses self-reported fatigue and its associated impact on daily activities over the past 7 days. A higher score indicates a better outcome (no fatigue). The total score ranges from 0 to 52, with 0 being the worst possible score and 52 being the best possible score (indicating no fatigue). |
| Secondary | Changes from Baseline in Patient Global Impression of Severity (PGIS) scores | Baseline and up to Week 156 | The PGIS is a single global question which asks participants to rate the severity of their VEXAS syndrome symptoms on a 5-point rating scale with response categories of "No symptoms", "Mild", "Moderate", "Severe", and "Very Severe." The PGIS scores ranges from 0 (absent) to 4 (very severe). |
| Secondary | Changes in Patient Global Impression of Change (PGIC) scores | Baseline and up to Week 156 | The PGIC is a single global question which asks participants to rate the change in severity of their VEXAS syndrome symptoms since starting study medication using a 5-point rating scale with response categories of "much better", "a little better", "no change", "a little worse", "much worse". The PGIC score ranges from +2 (much better) to -2 (much worse). |
| Secondary | Changes from Baseline in European quality of life 5 dimensions 5 level version (EQ-5D-5L) | Baseline and up to Week 48 | EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by 5-point Likert scale ranging from 1=no problems to 5=extreme problems. |
| Secondary | Changes from Baseline in European quality of life-Visual Analogue Scale (EQ-VAS) | Baseline and up to Week 48 | The EQ-VAS records the respondents self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. |
| Secondary | Number of participants with adverse events (AEs) and Serious adverse events (SAEs) | Up to Week 108 | |
| Secondary | Number of participants with adverse events (AEs) and Serious adverse events (SAEs) by severity | Up to Week 108 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07569081/registered