Study of IMG-007 in Participants with Moderate to Severe Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inmagene LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

completed 27 Apr 2024

Decision date (initial)

2024-03-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Inmagene LLC

External identifiers

EU CT number

2023-505735-13-01

WHO UTN

U1111-1290-9080

ClinicalTrials.gov

NCT05984784

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy, Therapy, Pharmacokinetic

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

Secondary objectives 2

1. 1. To characterize the pharmacokinetic (PK) profile of IMG-007 in AD participants
2. 2. To evaluate the efficacy of IMG-007 in AD participants as measured by eczema area and severity index (EASI) at Week 12

Conditions and MedDRA coding

Atopic dermatitis

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1) Male or female aged ≥ 18 and < 75 years.
2. 2) Voluntarily signed informed consent to participate in the study
3. 3) Diagnosed with AD for ≥ 6 months according to the American Academy of Dermatology Consensus diagnostic criteria at the Screening visit.
4. 4) Moderate-to-severe AD, defined as: a) EASI score ≥ 12 at the Screening visit and ≥ 16 at the Baseline visit b) IGA ≥ 3 at the Screening visit and the Baseline visit c) Body surface area (BSA) ≥ 10% at the Screening visit and the Baseline visit
5. 5) Documented history of inadequate response or lack of tolerability or for whom topical treatments are otherwise inadvisable.
6. 6) Agree to apply a stable dose of a non-medicated emollient (moisturizer).
7. 7) Female participants who are not pregnant or breastfeeding, or female of childbearing potential who agrees to use a highly effective method of contraception or to practice true abstinence during the study
8. 8) Male participants must agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potential. Other protocol defined inclusion criteria might apply

Exclusion criteria 17

1. 1) Severe systemic diseases that could increase the risk associated with study participation or could interfere with the interpretation of study results and would make the patient inappropriate for entry into the study. Please refer to the Protocol for more information on the Exclusion criteria No.1.
2. 2) History of clinically significant abnormal laboratory values, as determined by the principal investigator, please refer to the Protocol for more information on the Exclusion criteria No.2.
3. 3) Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) serology results at Screening visit.
4. 4) Evidence of active or latent tuberculosis (TB) as confirmed by the screening TB test.
5. 5) History of untreated or inadequately treated TB infection.
6. 6) Active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the Screening and Baseline (Day 1) visit.
7. 7) Active unstable skin conditions in addition to AD that would interfere with the assessment of AD.
8. 8) Use of topical treatments for AD within 2 weeks before the Baseline (Day 1) visit.
9. 9) Use of phototherapy for AD with ultraviolet (UV) A or UVB or regular use of a tanning booth within 4 weeks before the Baseline (Day 1) visit.
10. 10) Use of non-biologic systemic (oral or injectable) agents including conventional immunosuppressants or immunomodulators and other approved drugs, within 4 weeks or 5 half-lives prior to the Baseline (Day 1) visit.
11. 11) Use of biologic therapy including approved and investigational agents within 3 months or 5 half-lives, prior to the Baseline (Day 1) visit.
12. 12) Receipt of a live (including live attenuated) vaccine within 2 months prior to the Baseline (Day 1) visit (participants must agree to avoid (including live attenuated) vaccination during study treatment and within 3 months thereafter).
13. 13) Any known hypersensitivity to any component of study treatment or other biologics
14. 14) Malignancy or a history of malignancy except for fully treated skin basal cell or non-metastatic squamous cell carcinomas; or cervical carcinoma in situ prior to the Screening visit.
15. 15) Planned major surgical procedure during the study.
16. 16) Participation in another research study involving an investigational product within 3 months prior to the Baseline (Day 1) visit.
17. 17) Women who are pregnant or nursing.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of TEAEs

Secondary endpoints 2

1. PK parameters as data permit
2. Percentage change in EASI from Baseline to Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inmagene LLC

Sponsor organisation

Inmagene LLC

Address

12526 High Bluff Drive Ste 345

City

San Diego

Postcode

92130-3015

Country

United States

Scientific contact point

Organisation

Inmagene LLC

Contact name

Regulatory Submissions

Public contact point

Organisation

Inmagene LLC

Contact name

Regulatory Submissions

Third parties 7

Locations

2 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications