Trial Outcomes & Findings for Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2 (NCT NCT04081220)
NCT ID: NCT04081220
Last Updated: 2025-09-10
Results Overview
ELN criteria
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-09-10
Participant Flow
Participant milestones
| Measure |
IMG-7289
IMG-7289: Single starting dose with individualized dose titrations throughout
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2
Baseline characteristics by cohort
| Measure |
IMG-7289
n=9 Participants
IMG-7289: Single starting dose with individualized dose titrations throughout
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Only 4 of the 5 completers were evaluable.
ELN criteria
Outcome measures
| Measure |
IMG-7289
n=4 Participants
IMG-7289: Single starting dose with individualized dose titrations throughout
|
|---|---|
|
The Proportion of Patients Who Achieve Complete Hematologic Remission at Week 24 Using ELN Response Criteria for ET (Barosi et al., 2013)
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 24 weeks to 48 weeks (may repeat)Symptom Forms will be completed by participants each week of participation in the study- even on weeks with no study visit. Symptom Form are completed at around the same time on each of the following days: Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71, Day 78, Day 85, Day 92, Day 99, Day 106, Day 113, Day 120, Day 127, Day 134, Day 141, Day 148, Day 155, Day 162 and Day 169.
Outcome measures
Outcome data not reported
Adverse Events
IMG-7289
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
IMG-7289
n=9 participants at risk
IMG-7289: Single starting dose with individualized dose titrations throughout
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Renal and urinary disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
Other adverse events
| Measure |
IMG-7289
n=9 participants at risk
IMG-7289: Single starting dose with individualized dose titrations throughout
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 2 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
2/9 • Number of events 2 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
2/9 • Number of events 3 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
3/9 • Number of events 3 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
44.4%
4/9 • Number of events 4 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Injury, poisoning and procedural complications
Bruising
|
44.4%
4/9 • Number of events 4 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Infections and infestations
Conjunctivitis
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Gastrointestinal disorders
Constipation
|
44.4%
4/9 • Number of events 6 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 9 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Nervous system disorders
Dysgeusia
|
77.8%
7/9 • Number of events 9 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
General disorders
Edema limbs
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 2 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
General disorders
Fatigue
|
44.4%
4/9 • Number of events 10 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
22.2%
2/9 • Number of events 3 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Number of events 2 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
3/9 • Number of events 5 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
General disorders
Malaise
|
33.3%
3/9 • Number of events 4 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Nervous system disorders
Memory impairment
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Reproductive system and breast disorders
Menorrhagia
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Number of events 13 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 2 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Gastrointestinal disorders
Periodontal disease
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Infections and infestations
Periorbital infection
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • Number of events 4 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Renal and urinary disorders
Urine discoloration
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Infections and infestations
COVID 19
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
General disorders
Chest pain
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Gastrointestinal disorders
Diverticulitis
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Reproductive system and breast disorders
Uterine Cramp
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Bursitis Left Shoulder
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Infections and infestations
Abscess cheek
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Low Back Spasm
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
|
Blood and lymphatic system disorders
Increased red blood cells
|
11.1%
1/9 • Number of events 1 • 24 weeks
AEs are assessed through regular investigator assessments and laboratory testing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place