Platform study to evaluate the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2025-09-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG, OMS ID: ORG-100003908

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Efficacy

To establish and characterize the dose-response relationship of respective intervention and estimate the targeted dose(s) treatment effect vs placebo with respect to the percentage change from baseline on EASI score at Week 16 in participants with moderate to severe AD

Secondary objectives 2

1. To establish and characterize the dose-response relationship of respective intervention (refer to Section 12) and estimate the targeted dose(s) treatment effect vs. placebo with respect to achievement of IGA response and EASI-75 response at Week 16 in participants with moderate to severe AD
2. To evaluate the safety and tolerability of respective intervention

Conditions and MedDRA coding

Moderate to severe atopic dermatitis

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Paul-Ehrlich-Institut

Plan to share IPD

Yes

IPD plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Able and willing to sign the informed consent
2. Patients with a diagnosis of AD and onset of disease for at least 1 year
3. Moderate to severe AD
4. History of inadequate response to treatment with topical medications or for whom topical treatments are medically inadvisable as per Investigator judgement

Exclusion criteria 5

1. Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)
2. Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG
3. Participant with any other active inflammatory skin disease
4. Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)
5. Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage change from baseline in the EASI score at Week 16

Secondary endpoints 3

1. IGA response at Week 16: IGA score of 0 (clear) or 1 (almost clear) and at least 2 points reduction from baseline IGA response at Week 16
2. EASI-75 response at Week 16: ≥75% reduction (improvement) from baseline in EASI score response at Week 16
3. Treatment emergent adverse events, vital signs, ECG, and laboratory assessments

Investigational products

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

Test 1

Placebo 1

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 11

Locations

9 EU/EEA countries · 52 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 71 files

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

Application history

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