Hidradenitis Suppurativa: Evaluation of Upadacitinib in Adult and Adolescent Subjects

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Abbvie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

26 Oct 2023 → ongoing

Decision date (initial)

2023-10-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-503661-28-00

ClinicalTrials.gov

NCT05889182

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective is to assess the efficacy and safety of upadacitinib compared with placebo in adults and adolescents with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.

Conditions and MedDRA coding

Hidradenitis Suppurativa

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency, Medical Products Agency, Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-001741-PIP08-22

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Subjects or their legally authorized representative (if required per local regulations) must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures
2. Subjects must be ≥ 12 years old at Screening Visit.
3. Body weight must be ≥ 30 kg at the Baseline Visit for subjects between ≥ 12 and < 18 years of age
4. Diagnosis of HS for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of subject).
5. Documented history of previous use of ≥ 1 TNF inhibitor for HS for at least 12 weeks and/or 1 approved nonanti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator
6. Subject must have a total AN count of ≥ 5 at Baseline.
7. HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
8. At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
9. Draining fistula count of ≤ 20 at Baseline.

Exclusion criteria 1

1. Subject has history of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the achievement of HiSCR 50 at Week 16. HiSCR 50 is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

Secondary endpoints 9

1. Change from Baseline in draining fistula count at Week 16;"
2. Achievement of HiSCR 75 (at least a 75% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to Baseline) at Week 16
3. Achievement of NRS30 (at least a 30% reduction and at least 2 units reduction from Baseline in the Patient's Global Assessment of HS-related skin pain NRS) at Week 4 among subjects with NRS ≥ 3 at Baseline. The NRS30 is based on worst skin pain in a 24-hour recall period (maximal daily pain);
4. Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) at Week 16
5. Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) at Week 16
6. Change from Baseline in Dermatology Life Quality Index (DLQI) for adult subjects and adolescent subjects age ≥ 16 years old at Week 16"
7. Change from Baseline in HS-related odor, based on HSSA Question 8, at Week 16.
8. Change from Baseline in the Patient's Global Assessment of HS-related skin pain NRS at Week 8
9. Occurrence of HS flare, defined as at least one occurrence of a ≥ 25% increase in AN count, with a minimum absolute increase of 2 relative to Baseline, during Period 1. "

Investigational products

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

Test 2

Placebo 1

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 10

Locations

18 EU/EEA countries · 94 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 257 files

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

Application history

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