Proof-of-concept study evaluating subcutaneous amlitelimab in adult participants with moderate to severe hidradenitis suppurativa.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Research & Development

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

15 Apr 2024 → 11 Oct 2025

Decision date (initial)

2024-02-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Développement

External identifiers

EU CT number

2023-505803-22-00

WHO UTN

U1111-1290-9497

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Efficacy, Pharmacodynamic, Safety

To evaluate the efficacy of amlitelimab in the subgroup of participants with HS

Secondary objectives 7

1. To evaluate the efficacy of amlitelimab in the subgroup of participants with HS
2. To evaluate the effect of amlitelimab on skin pain in the subgroup of participants with HS
3. To evaluate the effect of amlitelimab on pruritus in the subgroup of participants with HS
4. To evaluate the effect of amlitelimab on quality of life in subgroup of participants with HS
5. To evaluate the safety and tolerability of amlitelimab in participants with HS
6. To characterize the pharmacokinetic profile of amlitelimab administered by SC injection in participants with HS
7. To characterize immunogenicity of amlitelimab administered by SC injection in participants with HS

Conditions and MedDRA coding

Hidradenitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participant must be 18 (or country’s age of majority if >18) years to 70 years of age inclusive, at the time of signing the informed consent.
2. Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
3. Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), 1 of which must be Hurley Stage II or Hurley Stage III.
4. Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS.

Exclusion criteria 2

1. Participants with a diagnosis of inflammatory conditions other than HS (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, multiple sclerosis, Behcet’s disease, sarcoidosis, etc).
2. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16

Secondary endpoints 17

1. Time to onset of achieving HiSCR50
2. Absolute change from baseline in AN count at Week 16
3. Percentage change in AN count at Week 16
4. Percentage of participants achieving HiSCR75 at Week 16
5. Percentage of participants achieving HiSCR90 at Week 16
6. Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16
7. Change in absolute score from Baseline in IHS4 at Week 16
8. Percentage of participants who experience a flare at Week 16
9. Percentage of participants achieving IHS4-55 at Week 16
10. Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily HS-Skin Pain NRS at Week 16 among participants with baseline NRS ≥3
11. Percentage of participants with improvement (reduction) in Peak Pruritus Numerical Rating Scale (PP-NRS) ≥4 from Baseline at Week 16 among participants with baseline PP-NRS ≥4
12. Percentage of participants who experience 5- point reduction in DLQI at Week 16 among participants with baseline DLQI ≥4
13. Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16
14. Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interest (AESIs), and serious adverse events (SAEs) including local injection site reactions in the Safety Population
15. Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population
16. Serum amlitelimab concentrations measured at prespecified time points in the PK population
17. Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Research & Development

Sponsor organisation

Sanofi-Aventis Research & Development

Address

1 Avenue Pierre Brossolette

City

Chilly Mazarin

Postcode

91380

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Research & Development

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Research & Development

Contact name

Clinical Sciences and Operations

Third parties 2

Locations

7 EU/EEA countries · 23 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 75 files

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

Application history

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