Atopic Dermatitis Clinical Trial
Official title:
A Phase1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of IMG-007 in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Verified date | May 2024 |
Source | Inmagene LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the safety of IMG-007 in adults with moderate-to-severe AD. The secondary objectives are to evaluate the pharmacokinetics and efficacy of IMG-007 in AD patients.
Status | Terminated |
Enrollment | 13 |
Est. completion date | April 26, 2024 |
Est. primary completion date | April 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 74 Years |
Eligibility | Key Inclusion Criteria: - Male or female aged = 18 and < 75 years. - Moderate-to-severe AD. - Documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the Screening visit, or for whom topical treatments are otherwise inadvisable. - Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception. 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. - Active unstable pruritic skin conditions in addition to AD that would interfere with the assessment of AD based on the investigator's clinical judgement. - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Brunswick Dermatology Center | Fredericton | New Brunswick |
Canada | DermEffects | London | Ontario |
Canada | Centre de Recherche Saint-Louis (Québec) | Québec | |
United States | Medical Research Center of Miami II Inc | Miami | Florida |
United States | Markowitz Medical, LLC | New York | New York |
United States | Amicis Research Center | Northridge | California |
United States | Central Sooner Research | Oklahoma City | Oklahoma |
United States | Optimal Research Sites | Orange City | Florida |
United States | Paddington Testing Co, Inc | Philadelphia | Pennsylvania |
United States | USF Carol and Frank Morsani Center for Advanced Healthcare | Tampa | Florida |
United States | Revival Research Institute, LLC | Troy | Michigan |
United States | Amicis Research Center | Valencia | California |
Lead Sponsor | Collaborator |
---|---|
Inmagene LLC |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Adverse Events in Participants | To evaluate adverse events (AEs) emergent from multiple doses of IMG-007 in adult participants with atopic dermatitis (AD) | Baseline, Week 24 | |
Secondary | Pharmacokinetic Characterization | To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment clearance (CL) in AD participants | Baseline, Week 24 | |
Secondary | Pharmacokinetic Characterization | To characterize the pharmacokinetic (PK) profile of multiple doses of IMG-007 in terms of the central compartment volume (Vc) in AD participants | Baseline, Week 24 | |
Secondary | Evaluation of Eczema Area and Severity Index (EASI) | To evaluate the efficacy of multiple doses of IMG-007 in AD participants as measured by the Eczema Area and Severity Index (EASI) | Baseline, Week 12 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05018806 -
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
|
Phase 2 | |
Terminated |
NCT03847389 -
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
|
Phase 1/Phase 2 | |
Completed |
NCT04090229 -
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
|
Phase 1 | |
Active, not recruiting |
NCT05388760 -
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
|
Phase 2 | |
Completed |
NCT05530707 -
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
|
N/A | |
Completed |
NCT02595073 -
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
|
Phase 3 | |
Recruiting |
NCT05509023 -
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
|
Phase 2 | |
Recruiting |
NCT05048056 -
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT04598269 -
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
|
Phase 2 | |
Recruiting |
NCT03936335 -
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
|
||
Withdrawn |
NCT03089476 -
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
|
N/A | |
Recruiting |
NCT05029895 -
A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
|
||
Terminated |
NCT03654755 -
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT04556461 -
Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function
|
Phase 2 | |
Recruiting |
NCT04818138 -
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
|
N/A | |
Completed |
NCT03719742 -
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
|
N/A | |
Completed |
NCT05375955 -
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
|
Phase 2 | |
Completed |
NCT03441568 -
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
|
N/A | |
Recruiting |
NCT06366932 -
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
|
Phase 4 | |
Completed |
NCT03304470 -
A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis
|
Phase 2 |