Hidradenitis Suppurativa: Evaluation of lutikizumab 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

12 Dec 2024 → ongoing

Decision date (initial)

2024-11-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Incl.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective is to assess the efficacy of lutikizumab versus placebo for the treatment of the signs and symptoms of moderate to severe HS in subjects 12 years of age and older.

Secondary objectives 5

1. During Period 1, to assess the safety and tolerability of lutikizumab versus placebo.
2. During Period 2, to assess the efficacy and safety of continuing lutikizumab dosing in Period 1 or switching to a lower dose in subjects who received lutikizumab in Period 1.
3. To evaluate the benefit of switching to lutikizumab in subjects who received placebo in Period 1.
4. During Periods 1 and 2, to assess the immunogenicity of lutikizumab.
5. During Period 3, to assess long term safety and efficacy of lutikizumab.

Conditions and MedDRA coding

Hidradenitis Suppurativa

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration, Pharmaceuticals And Medical Devices Agency

EMA paediatric investigation plan (PIP)

EMEA-003481-PIP01-23

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 6

1. Subjects must be ≥12 years of age (or ≥16 in countries where <16 is not permitted, or ≥18 in countries where <18 is not permitted) at the screening visit.
2. Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of subject).
3. Total AN count of ≥ 5 at Baseline.
4. HS lesions present in at least two distinct anatomic areas at Baseline.
5. At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
6. Subjects must have had an inadequate response per investigator's judgement to a 12-week trial (or an adequate trial per local treatment guidelines) of oral antibiotics for treatment of HS or demonstrated intolerance to oral antibiotics for HS treatment.

Exclusion criteria 1

1. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: • Serum AST > 2 × ULN; • Serum ALT > 2 × ULN; • Serum total bilirubin > 2.0 mg/dL, except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome; • Total WBC count < 3,000/µL; • ANC < 2,000/µL; • Platelet count < 100,000/µL; • Hemoglobin < 9.0 g/dL.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the achievement of HiSCR 75 at Week 16. HiSCR 75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline.

Secondary endpoints 12

1. Ranked Secondary Endpoints: 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 8 among subjects with NRS ≥ 3 at Baseline. The NRS30 is based on worst skin pain in a 24-hour recall period (maximal daily pain); "
2. Change from Baseline in DLQI at Week 16 among subjects ≥ 16 years of age at Baseline;
3. Change from Baseline in HSIA at Week 16
4. Change from Baseline in HSSA Worst Drainage Score at Week 16;
5. Change from Baseline in Draining Fistula at Week 16 among subjects with at least 1 draining fistula at Baseline;
6. Achievement of HiSCR 90 (at least a 90% 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;
7. Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) at Week 8;
8. Change from Baseline in HSSA at Week 16;
9. Change from Baseline in HS-related odor (smell), based on HSSA Question 8, at Week 16;
10. 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 the first 16 weeks (Period 1).
11. Change from Baseline in HSIA Emotional Domain at Week 16;
12. Change from Baseline in HSIA Mobility Domain at Week 16.

Investigational products

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

Test 1

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 8

Locations

22 EU/EEA countries · 103 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 2 · Art. 77 CTR

Results and documents

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

Documents 220 files

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

Application history

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