A study to assess different investigational drugs for the treatment if hidradenitis suppurativa

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

17 Jun 2019 → 21 Oct 2025

Decision date (initial)

2024-05-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-509296-16-00

EudraCT number

2018-002757-30

ClinicalTrials.gov

NCT03827798

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacogenetic, Safety, Efficacy, Pharmacokinetic

To assess the efficacy of the investigational treatments, compared to placebo in moderate to severe inflammatory HS patients

Secondary objectives 1

1. To assess the safety and tolerability of the investigational treatments in patients with moderate to severe HS

Conditions and MedDRA coding

Moderate to severe hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male and female patients, 18 to 65 years of age (inclusive), with clinically diagnosed HS for at least 12 months prior to Screening.
2. For Cohort A (iscalimab), C (MAS825) and E (VAY736): A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules.
3. For Cohort B (LYS006) and D (LOU064): A total of at least 3 inflammatory lesions, i.e., abscesses and/or inflammatory nodules.
4. For all Cohorts: No more than 15 fistulae and at least two anatomical areas need to be involved with HS lesions.

Exclusion criteria 3

1. Use of other investigational drugs at the time of screening, or within 30 days or 5 half-lives of randomization, whichever is longer; or longer if required by local regulations.
2. Use/receipt of some specific treatments during specified time frames, depending on the cohort.
3. WoCBP, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for the subsequent 14 weeks after the last study drug administration for Cohort A (iscalimab) and the subsequent 2 weeks after the last study drug administration for Cohort B (LYS006) and D (remibrutinib). In Cohort C, WoCBP will be asked to adhere to highly effective contraception from at least 3 months prior to first drug administration and until 5 months after the final dose (Day 225 to Day 253), when a pregnancy test will be conducted. In Cohort E, WoCBP will be required to adhere to highly effective contraception for 6 months after the final dose (Day 253 to Day 281).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients achieving clinical response evaluated by the simplified Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment

Secondary endpoints 2

1. Number and severity of adverse events
2. Physical examination, vital signs, safety laboratory measurements, ECGs

Investigational products

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

Test 1

Placebo 1

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 17

Locations

6 EU/EEA countries · 15 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 82 files

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

Application history

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