Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease (NCT NCT05424276)

NCT ID: NCT05424276

Last Updated: 2025-11-19

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2025-11-19

Participant Flow

Participants were recruited from 32 clinical sites in the United States including both private clinics and public institutions. A total of 137 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	50mg IkT-148009 (Risvodetinib) This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo This arm will consist participants treated with placebo for 12 weeks.
Overall Study STARTED	35	34	33	35
Overall Study COMPLETED	31	31	28	30
Overall Study NOT COMPLETED	4	3	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	50mg IkT-148009 (Risvodetinib) This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo This arm will consist participants treated with placebo for 12 weeks.
Overall Study Adverse Event	1	0	0	2
Overall Study Withdrawal by Subject	0	0	2	0
Overall Study Protocol Violation	0	1	0	0
Overall Study Subjects Withdrawn due to regulatory hold	3	2	3	3

Baseline Characteristics

A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	50mg IkT-148009 (Risvodetinib) n=35 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=34 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=33 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=35 Participants This arm will consist participants treated with placebo for 12 weeks.	Total n=137 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 7.79	63.3 years STANDARD_DEVIATION 8.08 • n=4 Participants	63.2 years STANDARD_DEVIATION 7.41 • n=8 Participants	64.9 years STANDARD_DEVIATION 7.20 • n=19 Participants	63.7 years STANDARD_DEVIATION 7.57 • n=526 Participants
Sex: Female, Male Female	12 Participants	16 Participants n=4 Participants	11 Participants n=8 Participants	16 Participants n=19 Participants	55 Participants n=526 Participants
Sex: Female, Male Male	23 Participants	18 Participants n=4 Participants	22 Participants n=8 Participants	19 Participants n=19 Participants	82 Participants n=526 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	3 Participants n=526 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants	1 Participants n=19 Participants	3 Participants n=526 Participants
Race (NIH/OMB) White	32 Participants	31 Participants n=4 Participants	32 Participants n=8 Participants	34 Participants n=19 Participants	129 Participants n=526 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	0 Participants n=526 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=19 Participants	2 Participants n=526 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	3 Participants n=4 Participants	0 Participants n=8 Participants	5 Participants n=19 Participants	14 Participants n=526 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants	31 Participants n=4 Participants	33 Participants n=8 Participants	29 Participants n=19 Participants	122 Participants n=526 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	1 Participants n=19 Participants	1 Participants n=526 Participants
Hoehn & Yahr H&Y 2.5	0 Participants	1 Participants n=4 Participants	0 Participants n=8 Participants	2 Participants n=19 Participants	3 Participants n=526 Participants
Hoehn & Yahr H&Y 2.0	20 Participants	21 Participants n=4 Participants	27 Participants n=8 Participants	25 Participants n=19 Participants	93 Participants n=526 Participants
Hoehn & Yahr H&Y 1.5	2 Participants	1 Participants n=4 Participants	3 Participants n=8 Participants	0 Participants n=19 Participants	6 Participants n=526 Participants
Hoehn & Yahr H&Y 1.0	13 Participants	9 Participants n=4 Participants	2 Participants n=8 Participants	8 Participants n=19 Participants	32 Participants n=526 Participants
Hoehn & Yahr Missing	0 Participants	2 Participants n=4 Participants	1 Participants n=8 Participants	0 Participants n=19 Participants	3 Participants n=526 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=35 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=34 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=33 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=35 Participants This arm will consist participants treated with placebo for 12 weeks.
Incidence of Treatment-emergent Adverse Events (TEAEs)	19 Participants	21 Participants	21 Participants	21 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=35 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=34 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=33 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=35 Participants This arm will consist participants treated with placebo for 12 weeks.
Proportion of Those Randomized in Each Dosing Cohort Who Discontinued the Assigned Regimen Due to an Adverse Event	1 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: The mITT population will include all randomized participants who have a valid baseline MDS-UPDRS, received at least one dose of study drug, and have at least one post-baseline evaluation of the MDS-UPDRS assessment as defined in the Statistical Analysis Plan

Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Parts II and III reflect assessments covering activites of daily living as reported by the participant (Part II) as well as a clinicians assessment of motor abilities (Part III). Part II consists of 13 items with total scores ranging from 0 to 52 while Part III consists of 18 items with total scores range from 0 to 132. Each item is scored 0 (normal) to 4 (severe). The sum of Parts 2 and 3 have a score range of 0 to 184 (31 total items). An increase in sum of Parts 2 and 3 relative to baseline represents a worsening of the participant's Parkinson's disease

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in MDS-UPDRS Part II+III From a Mixed Model for Repeated Measures	0.08 Score on the Scale Interval -2.585 to 2.745	1.82 Score on the Scale Interval -0.794 to 4.433	2.12 Score on the Scale Interval -0.627 to 4.871	0.85 Score on the Scale Interval -1.791 to 3.488

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

Parkinson's Disease Questionnaire (PDQ) consists of 39 questions evaluating activities of daily living. Participants rate each question on a 5 point scale (0 to 4), . The PDQ-39 score ranges from 0 to 100 with higher score representing more advanced disease.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in PDQ-39 From a Mixed Model for Repeated Measures	-1.90 Assessment Score Interval -3.434 to -0.364	-0.99 Assessment Score Interval -2.494 to 0.515	-1.89 Assessment Score Interval -3.478 to -0.308	-2.35 Assessment Score Interval -3.868 to -0.824

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

Patient Global Impression - Severity (PGI-S) is participant reported assessment designed to evaluate the severity of their Parkinson's Disease. Scores range from 1 to 4 with 1 considered Normal and 4 considered Severe.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in PGI-S From a Mixed Model for Repeated Measures	0.04 score on a scale Interval -0.114 to 0.203	0.13 score on a scale Interval -0.023 to 0.279	0.03 score on a scale Interval -0.134 to 0.185	-0.04 score on a scale Interval -0.193 to 0.118

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

Clinician Global Impression - Severity (CGI-S) is clinician reported assessment designed to evaluate the severity of a participants Parkinson's disease. Scores range from 1 to 7 with 1 considered "Normal" and 7 considered "Among the most extremely ill patients".

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in CGI-S From a Mixed Model for Repeated Measures	-0.08 score on a scale Interval -0.291 to 0.122	0.13 score on a scale Interval -0.076 to 0.329	-0.02 score on a scale Interval -0.23 to 0.195	0.11 score on a scale Interval -0.09 to 0.317

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part II assesses activities of daily living as reported by the participant. Part II consists of 13 items with a total score ranging from 0 to 52. Each item is scored 0 (normal) to 4 (severe). Higher scores reflect increased severity of disease.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in MDS-UPDRS Part II From a Mixed Model for Repeated Measures	0.11 Scale score Interval -0.836 to 1.047	-0.32 Scale score Interval -1.243 to 0.604	-0.08 Scale score Interval -1.051 to 0.894	1.09 Scale score Interval 0.157 to 2.02

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part III is completed by clinician and assesses a participants motor function. Part III consists of 18 items with a total score ranging from 0 to 132. Each item is scored 0 (normal) to 4 (severe). Higher scores reflect increased severity of disease.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in MDS-UPDRS Part III From a Mixed Model for Repeated Measures	-0.04 Assessment Score Interval -2.381 to 2.309	2.14 Assessment Score Interval -0.161 to 4.438	2.20 Assessment Score Interval -0.216 to 4.62	-0.21 Assessment Score Interval -2.534 to 2.112

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Part I assesses non-motor experiences of daily living. Part I is made up of two section with one rated by the investigator and another completed by the participant. Part I consists of 13 items with a total score ranging from 0 to 52. Each item is scored 0 (normal) to 4 (severe). Higher scores reflect increased severity of disease.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in MDS-UPDRS Part I From a Mixed Model for Repeated Measures	-0.93 Assesment Score Interval -1.842 to -0.028	-1.03 Assesment Score Interval -1.919 to -0.133	0.22 Assesment Score Interval -0.716 to 1.161	-0.26 Assesment Score Interval -1.159 to 0.638

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

Non-Motor Symptom Score (NMSS) is a 30 question assessment completed by the clinician designed to evaluate the non-motor symptoms of Parkinson's disease. Scores range from 0 to 360 with higher scores reflect increasing severity of disease

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in NMSS From a Mixed Model for Repeated Measures	0.14 Assessment score Interval -5.303 to 5.581	0.79 Assessment score Interval -4.451 to 6.032	0.88 Assessment score Interval -4.676 to 6.435	-0.14 Assessment score Interval -5.47 to 5.196

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

The Complete Spontaneous Bowel Movement (CSBM) Diary is a participant-completed paper diary used to record bowel movement activity over a 7-day period. Each entry captures the date and time of the bowel movement, stool consistency (Bristol Stool Form Scale), and whether the bowel movement was spontaneous (no laxative or rescue medication within the previous 24 hours) and complete (a sensation of full evacuation). The weekly CSBM score is calculated as the total number of complete and spontaneous bowel movements recorded during the 7-day period. Rome IV criteria defines constipation as having less than 3 CSBMs per 7 day period. A decrease in CSBM score represents a decrease in bowel function.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in CSBM Score From a Mixed Model for Repeated Measures	-0.04 Number of bowel movements per week Interval -0.963 to 0.875	0.30 Number of bowel movements per week Interval -0.588 to 1.189	-0.11 Number of bowel movements per week Interval -1.012 to 0.794	0.85 Number of bowel movements per week Interval -0.062 to 1.767

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

The Epworth Sleepiness Scale is a self-administered questionnaire that measures a participant's general level of daytime sleepiness. Participants rate their likelihood of dozing off or falling asleep in eight common situations using a 4-point scale from 0 = would never doze to 3 = high chance of dozing. The total ESS score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in ESS From a Mixed Model for Repeated Measures	-0.46 Assessment Score Interval -1.277 to 0.356	-0.30 Assessment Score Interval -1.081 to 0.472	-0.76 Assessment Score Interval -1.58 to 0.054	-0.68 Assessment Score Interval -1.485 to 0.122

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

Schwab and England Activies of Daily Living (SE-ADL) is a clinician administered assessment whereby participants assess their ability to complete routine daily activities on a scale from 0 to 100. The score is reported in increments of 10 with 100 representing normal ability to complete daily activities.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in SE-ADL From a Mixed Model for Repeated Measures	0.02 Assessment Score Interval -0.001 to 0.038	-0.00 Assessment Score Interval -0.019 to 0.018	-0.00 Assessment Score Interval -0.023 to 0.017	-0.02 Assessment Score Interval -0.04 to -0.002

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

The Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) is a participant-reported questionnaire designed to assess the severity of upper gastrointestinal symptoms over the previous two weeks. The instrument includes 20 items. Each item is rated on a 6-point Likert scale from 0 = none to 5 = very severe, with higher scores indicating greater symptom severity. A total score is calculated as the mean of non-missing item responses.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in PAGI-SYM From a Mixed Model for Repeated Measures	-0.04 Assessment score Interval -0.179 to 0.089	-0.02 Assessment score Interval -0.154 to 0.109	-0.09 Assessment score Interval -0.229 to 0.05	0.05 Assessment score Interval -0.083 to 0.183

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

The Patient Assessment of Constipation Quality of Life (PAC-QOL) is a participant-reported questionnaire that evaluates the impact of constipation and its treatment on quality of life over the previous two weeks. It consists of 28 items. Each item is rated on a 5-point Likert scale from 0 = not at all / very satisfied to 4 = extremely / very dissatisfied, depending on item phrasing. Scores are calculated as the mean of all non-missing items, with higher scores indicating greater negative impact on quality of life.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in PAC-QoL From a Mixed Model for Repeated Measures	-0.03 Assessment Score Interval -0.173 to 0.12	-0.17 Assessment Score Interval -0.31 to -0.027	-0.13 Assessment Score Interval -0.277 to 0.023	-0.03 Assessment Score Interval -0.177 to 0.111

SECONDARY outcome

Timeframe: Change from Baseline to Week 12

The Patient Assessment of Upper Gastrointestinal Disorders Quality of Life (PAGI-QOL) is a validated, participant-reported questionnaire that assesses the impact of upper gastrointestinal symptoms on quality of life over the previous two weeks. The instrument includes 30 items. Each item is rated on a 6-point Likert scale from 0 = none of the time to 5 = all of the time. Scores are calculated as the mean of all non-missing items, with lower scores represent a greater negative impact on a participant's quality of life.

Outcome measures

Outcome measures
Measure	50mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=32 Participants This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=29 Participants This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=32 Participants This arm will consist participants treated with placebo for 12 weeks.
LS Mean of Change From Baseline in PAGI-QoL From a Mixed Model for Repeated Measures	0.07 Assessment score Interval -0.014 to 0.15	0.06 Assessment score Interval -0.023 to 0.139	0.06 Assessment score Interval -0.03 to 0.141	0.05 Assessment score Interval -0.029 to 0.135

Adverse Events

50mg IkT-148009 (Risvodetinib)

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

100mg IkT-148009 (Risvodetinib)

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

200mg IkT-148009 (Risvodetinib)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	50mg IkT-148009 (Risvodetinib) n=35 participants at risk This arm consisted of participants treated with the 50mg dose of risvodetinib for 12 weeks.	100mg IkT-148009 (Risvodetinib) n=34 participants at risk This arm consisted of participants treated with the 100mg dose of risvodetinib for 12 weeks.	200mg IkT-148009 (Risvodetinib) n=33 participants at risk This arm consisted of participants treated with the 200mg dose of risvodetinib for 12 weeks.	Placebo n=35 participants at risk This arm will consist participants treated with placebo for 12 weeks.
Injury, poisoning and procedural complications Femur Fracture	2.9% 1/35 • Number of events 1 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	0.00% 0/34 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	0.00% 0/33 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	0.00% 0/35 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance
Infections and infestations Infection of Finger	0.00% 0/35 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	0.00% 0/34 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	3.0% 1/33 • Number of events 1 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	0.00% 0/35 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance
Infections and infestations Diverticulitis	0.00% 0/35 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	0.00% 0/34 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	0.00% 0/33 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance	2.9% 1/35 • Number of events 1 • Enrollment until the end of follow up (14 weeks post baseline visit) All adverse event recordings were done in compliance with ICH and FDA guidance

Other adverse events

Additional Information

Milton Werner

ABLi Therapeutics

Phone: 9174940831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Upon completion of the Study and evaluation by Sponsor of all data from the Study, or upon early termination or abandonment of the Study, Institution and Investigator may publish or otherwise publicly disclose, for non-commercial purposes, Study Data .
Publication restrictions are in place

Restriction type: OTHER