ClinicalTrials.Veeva

Menu
The trial is taking place at:
O

Options Research Group | West Lafayette, Indiana

Veeva-enabled site

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants

I

Inmagene

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Alopecia Areata (AA)

Treatments

Drug: IMG-007

Study type

Interventional

Funder types

Industry

Identifiers

NCT06060977
IMG-007-202

Details and patient eligibility

About

The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.

Full description

This is a phase 1b/2a, open label study to assess the safety, PK, and efficacy of IMG-007 in adult AA participants with 50% or greater scalp hair loss. The study will consist of two cohorts with three periods: a screening period of up to 5 -weeks, a 16-week treatment period and an 8-week follow- up period. Approximately 6 and 24 participants will be sequentially enrolled into cohort 1 and cohort 2, respectively, to receive three intravenous infusions of IMG-007 over 4 weeks.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Male or female aged ≥ 18 and ≤ 65 years
  • AA with current episode of hair loss of > 6 months but < 8 years
  • AA with ≥ 50% scalp involvement as defined as SALT score ≥ 50

Key Exclusion Criteria:

  • Known hepatitis B, hepatitis C, or human immunodeficiency virus infection
  • Evidence of active or latent tuberculosis (TB)
  • History of untreated or inadequately treated TB infection.
  • Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening visit
  • Concurrent hair loss due to other etiologies
  • Primary "diffuse" type of AA
  • Active inflammatory diseases on the scalp that would interfere with the assessment of AA
  • History or presence of hair transplants or micropigmentation of the scalp
  • Active systemic diseases that may cause hair loss
  • Other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

30 participants in 2 patient groups

IMG-007 Dose 1
Experimental group
Description:
IMG-007 Dose 1 will be administered intravenously 3 times over 4 weeks
Treatment:
Drug: IMG-007
IMG-007 Dose 2
Experimental group
Description:
IMG-007 Dose 2 will be administered intravenously 3 times over 4 weeks
Treatment:
Drug: IMG-007

Trial contacts and locations

17

Loading...

Central trial contact

Duong Nguyen

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems