Trial Outcomes & Findings for A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD) (NCT NCT05984784)

Last Updated: 2025-11-06

Results Overview

To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD)

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 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

2025-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 IMG-007 Dose 1 IMG-007 Dose 1 was to be administered intravenously 3 times over 4 weeks IMG-007: Drug: IMG-007 Intravenous Infusion
Overall Study STARTED	13
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adults With Atopic Dermatitis (AD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 IMG-007 Dose 1 n=13 Participants IMG-007 Dose 1 was to be administered intravenously 3 times over 4 weeks IMG-007: Drug: IMG-007 Intravenous Infusion
Age, Continuous	49.8 years STANDARD_DEVIATION 15.0 • n=49 Participants
Sex: Female, Male Female	4 Participants n=49 Participants
Sex: Female, Male Male	9 Participants n=49 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=49 Participants
Race (NIH/OMB) Asian	0 Participants n=49 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants
Race (NIH/OMB) Black or African American	7 Participants n=49 Participants
Race (NIH/OMB) White	6 Participants n=49 Participants
Race (NIH/OMB) More than one race	0 Participants n=49 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=49 Participants
EASI score	29.5 units on a scale STANDARD_DEVIATION 13.7 • n=49 Participants

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 atopic dermatitis (AD)

Outcome measures

Outcome measures
Measure	Cohort 1 IMG-007 Dose 1 n=13 Participants IMG-007 Dose 1 was to be administered intravenously 3 times over 4 weeks IMG-007: Drug: IMG-007 Intravenous Infusion
Evaluation of Adverse Events in Participants Participants with at least 1 TEAE	9 participants
Evaluation of Adverse Events in Participants SAE	0 participants
Evaluation of Adverse Events in Participants Investigational product-related TEAE	0 participants
Evaluation of Adverse Events in Participants TEAE that was an infusion-related reaction	0 participants
Evaluation of Adverse Events in Participants TEAE leading to 4-week dosing period discontinuation	0 participants
Evaluation of Adverse Events in Participants TEAE with outcome of death	0 participants

SECONDARY outcome

Timeframe: Serum concentrations of IMG-007 were measured at Week 4 (pre-dose and post-dose), Week 12 (post-dose), and Week 24 (post-dose).

To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in AD participants

Outcome measures

Outcome measures
Measure	Cohort 1 IMG-007 Dose 1 n=13 Participants IMG-007 Dose 1 was to be administered intravenously 3 times over 4 weeks IMG-007: Drug: IMG-007 Intravenous Infusion
Pharmacokinetic Characterization Week 4, Pre-dose	47650.0 ng/mL Standard Deviation 16255.6
Pharmacokinetic Characterization Week 4, Post-dose	131400.0 ng/mL Standard Deviation 18379.3
Pharmacokinetic Characterization Week 12, Post-dose	16088.0 ng/mL Standard Deviation 12662.2
Pharmacokinetic Characterization Week 24, Post-Dose	1334.2 ng/mL Standard Deviation 1720.5

SECONDARY outcome

Timeframe: Mean percent change from baseline in Eczema Area and Severity Index (EASI) at week 12.

The Eczema Area and Severity Index (EASI) is a validated composite scoring system assessed by the investigator based on the body area involved in each of the four body regions (head and neck, upper limbs, lower limbs, and trunk) and the average severity of each of the four key signs of AD (erythema, edema/papulation, excoriation, and lichenification) based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The total EASI score ranges from 0 (clear or no eczema) to 72 (maximum severity), with higher values indicating more severe and/or extensive disease.

Outcome measures

Outcome measures
Measure	Cohort 1 IMG-007 Dose 1 n=13 Participants IMG-007 Dose 1 was to be administered intravenously 3 times over 4 weeks IMG-007: Drug: IMG-007 Intravenous Infusion
Evaluation of Eczema Area and Severity Index (EASI)	-68.5 percentage of change Standard Error 11.4

Adverse Events

Cohort 1 IMG-007 Dose 1

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 IMG-007 Dose 1 n=13 participants at risk IMG-007 Dose 1 was to be administered intravenously 3 times over 4 weeks IMG-007: Drug: IMG-007 Intravenous Infusion
Skin and subcutaneous tissue disorders Dermatitis atopic	30.8% 4/13 • 24 weeks
Skin and subcutaneous tissue disorders Urticaria	15.4% 2/13 • 24 weeks
Vascular disorders Hypertension	15.4% 2/13 • 24 weeks
Infections and infestations COVID-19	7.7% 1/13 • 24 weeks
Infections and infestations localized infection	7.7% 1/13 • 24 weeks
Infections and infestations Nasopharyngitis	7.7% 1/13 • 24 weeks
Gastrointestinal disorders Constipation	7.7% 1/13 • 24 weeks
Metabolism and nutrition disorders Dyslipidaemia	7.7% 1/13 • 24 weeks
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • 24 weeks
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • 24 weeks
Nervous system disorders Headache	7.7% 1/13 • 24 weeks
Respiratory, thoracic and mediastinal disorders Asthma	7.7% 1/13 • 24 weeks

Additional Information

Clinical Trials Lead

Inmagene LLC

Phone: (858) 345-6927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER