This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

31 May 2023 → 15 Aug 2024

Decision date (initial)

2023-09-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-504869-23-00

EudraCT number

2022-000434-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacogenetic, Dose response

1. Sub-Study 1 (SS1): The primary study objective for SS1 is to evaluate the efficacy and safety of dose escalation to upadacitinib 30 mg QD in subjects who do not achieve Eczema Area and Severity Index (EASI) 90 on upadacitinib 15 mg QD after 12 weeks.
2. Sub-Study 2 (SS2): The primary study objective for SS2 is to evaluate the efficacy and safety of dose reduction to upadacitinib 15 mg QD in subjects who achieve EASI 90 on upadacitinib 30 mg QD after 12 weeks. No hypothesis testing will be performed in this study.

Conditions and MedDRA coding

Dermatitis atopic

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Male or female subjects ≥18 and < 65 years of age at the Screening Visit
2. Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria
3. Candidate for systemic treatment

Exclusion criteria 4

1. Prior exposure to any JAK inhibitor
2. Unable or unwilling to discontinue current AD treatments prior to the study
3. Requirement of prohibited medications during the study treatment
4. Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Achievement of EASI 90 at Week 24

Secondary endpoints 13

1. Achievement of EASI 75 / 100 at Week 24.
2. Achievement of EASI 75 / 90 / 100 at Week 12.
3. Achievement of EASI 90 and a Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12 and Week 24.
4. Achievement of a vIGA-AD of 0 or 1 at Week 12.
5. Achievement of vIGA-AD of 0 or 1 at Week 24.
6. Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 12.
7. Achievement of an improvement (reduction) in Worst Pruritus NRS ≥ 4 for subjects with Worst Pruritus NRS ≥ 4 at Baseline at Week 24.
8. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 12.
9. Achievement of Worst Pruritus NRS of 0 or 1 for subjects with Worst Pruritus NRS > 1 at Baseline at Week 24.
10. Achevement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 12.
11. Achievement of an improvement (reduction) from Baseline in DLQI ≥4 for subjects with DLQI ≥ 4 at Baseline at Week 24.
12. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 12.
13. Achievement of DLQI 0/1 for subjects with DLQI > 1 at Baseline at Week 24.

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 4

Locations

10 EU/EEA countries · 63 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 14 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