A Study to Assess the Efficacy and Safety of RO7790121 in Patients with Moderate to Severe Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

F. Hoffmann-La Roche AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune System Phenomena [G13]

Trial duration

26 May 2025 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

F. Hoffmann-La Roche AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic

To evaluate the efficacy of RO7790121 compared with placebo in achieving Eczema Area and Severity Index (EASI)-75 response ( ≥ 75% improvement from baseline) at Week 16

Secondary objectives 5

1. To evaluate the efficacy of RO7790121 compared with placebo in achieving : – Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) with ≥ 2-grade improvement at Week 16 and Week 32 – EASI-75 responset at Week 32 – EASI-90 response at Week 16 and Week 32. – Percent change from baseline in EASI by visit
2. To evaluate the efficacy of RO7790121 compared with placebo in achieving improvement in participant-reported outcomes (PROs)
3. To characterize the dose response efficacy of RO7790121
4. To evaluate the safety of RO7790121 compared with placebo
5. To characterize the pharmacokinetics (PK) of RO7790121

Conditions and MedDRA coding

Moderate to Severe Atopic Dermatitis (AD)

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Atopic Dermatitis-Specific AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening
2. Atopic Dermatitis-Specific Moderate to severe AD as defined by – EASI score ≥ 16 at screening and baseline visits, – IGA score ≥ 3 (5-point scale) at screening and baseline visits, and – AD involvement of ≥10% body surface area (BSA) at screening and baseline visits
3. Atopic Dermatitis-Specific At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study

Exclusion criteria 5

1. Atopic Dermatitis-Specific Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis
2. Prohibited Medications IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study
3. Prohibited Medications Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study
4. Infection or Infection Risk Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline
5. Infection or Infection Risk Acquired or congenital immunodeficiency Prohibited Medications Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Proportion of participants who achieve eczema area and severity index-75 (EASI-75) response (≥ 75% improvement from baseline) Week 16

Secondary endpoints 11

1. 1. Proportion of participants who achieve Investigator global assessment (IGA) score of clear (0) or almost clear (1) with ≥ 2-grade improvement at Week 16 and Week 32
2. 2. Proportion of participants who achieve EASI-75 response at Week 32
3. 3. Proportion of participants who achieve EASI-90 response at Week 16 and Week 32
4. 4. Percent change from baseline in EASI by visit
5. 5. Percent change from baseline in peak pruritus Numerical Rating Scale (NRS) score by visit
6. 6. Change from baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by visit
7. 7. Proportion of EASI-75 responders at week 16
8. 8. Incidence and severity of the following: – Adverse events – Serious adverse events – Adverse events leading to study treatment discontinuation – Adverse events of special interest
9. 9. Change from baseline in selected vital signs
10. 10. Change from baseline in selected clinical laboratory test results
11. 11. Serum concentration of RO7790121 at specified timepoints

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

F. Hoffmann-La Roche AG

Sponsor organisation

F. Hoffmann-La Roche AG

Address

Grenzacherstrasse 124

City

Basel

Postcode

4058

Country

Switzerland

Scientific contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Public contact point

Organisation

F. Hoffmann-La Roche AG

Contact name

Trial Information System - TISL

Third parties 7

Locations

5 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 84 files

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

Application history

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