Trial Outcomes & Findings for A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants (NCT NCT06060977)
NCT ID: NCT06060977
Last Updated: 2026-02-09
Results Overview
To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
Results posted on
2026-02-09
Participant Flow
Participant milestones
| Measure |
IMG-007 300 mg
IMG-007 300 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
IMG-007 600 mg
IMG-007 600 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
23
|
|
Overall Study
COMPLETED
|
5
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
IMG-007 300 mg
IMG-007 300 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
IMG-007 600 mg
IMG-007 600 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
Baseline characteristics by cohort
| Measure |
IMG-007 300 mg
n=6 Participants
IMG-007 300 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
IMG-007 600 mg
n=23 Participants
IMG-007 600 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=41 Participants
|
23 Participants
n=1581 Participants
|
29 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 15.51 • n=41 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
44.7 years
STANDARD_DEVIATION 15.05 • n=1581 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
44.2 years
STANDARD_DEVIATION 14.90 • n=4626 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
16 Participants
n=1581 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
22 Participants
n=4626 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
7 Participants
n=1581 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
7 Participants
n=4626 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
2 Participants
n=1581 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
2 Participants
n=4626 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=41 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
21 Participants
n=1581 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
27 Participants
n=4626 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
0 Participants
n=1581 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
0 Participants
n=4626 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
|
Severity of ALopecia Tool (SALT) Score
|
87.23 units on a scale
STANDARD_DEVIATION 15.651 • n=41 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
78.63 units on a scale
STANDARD_DEVIATION 18.401 • n=1581 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
80.41 units on a scale
STANDARD_DEVIATION 17.954 • n=4626 Participants • The analysis was based on patients who received IMG-007 300 mg, IMG-007 600 mg and Combined IMG-007.
|
PRIMARY outcome
Timeframe: Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with AA.
Outcome measures
| Measure |
IMG-007 600 mg
n=23 Participants
IMG-007 600 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
IMG-007 300 mg
n=6 Participants
IMG-007 300 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
|---|---|---|
|
Evaluation of Adverse Events in Participants
Participants with at least 1 TEAE
|
19 Participants
|
3 Participants
|
|
Evaluation of Adverse Events in Participants
SAE
|
0 Participants
|
0 Participants
|
|
Evaluation of Adverse Events in Participants
TEAE that was an infusion-related reaction
|
0 Participants
|
1 Participants
|
|
Evaluation of Adverse Events in Participants
TEAE leading to 4-week dosing period discontinuation
|
0 Participants
|
0 Participants
|
|
Evaluation of Adverse Events in Participants
TEAE with outcome of death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Mean percent change from baseline in Severity of ALopecia Tool (SALT) at week 24.To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by the Severity of Alopecia Tool (SALT). The Severity of Alopecia Tool (SALT) is a quantitative assessment of AA severity by the investigator based on scalp terminal hair loss. To evaluate the efficacy of multiple doses of IMG-007 in AA participants as measured by Severity of Alopecia Tool (SALT) on a scale of 0 for no hair loss, and 100 is complete hair loss (higher scores attributes to worse outcomes).
Outcome measures
| Measure |
IMG-007 600 mg
n=23 Participants
IMG-007 600 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
IMG-007 300 mg
n=6 Participants
IMG-007 300 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
|---|---|---|
|
Evaluation of Severity of Alopecia Tool (SALT)
|
-14.32 percentage of change
Standard Error 3.875
|
-1.07 percentage of change
Standard Error 7.593
|
Adverse Events
IMG-007 300 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
IMG-007 600 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IMG-007 300 mg
n=6 participants at risk
IMG-007 300 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
IMG-007 600 mg
n=23 participants at risk
IMG-007 600 mg will be administered intravenously 3 times over 4 weeks
IMG-007: Intravenous Infusion
|
|---|---|---|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/6 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
8.7%
2/23 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
8.7%
2/23 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
8.7%
2/23 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
8.7%
2/23 • Adverse events were collected from baseline through the end of the study, a period of up to 24 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER