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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06118099




Registration number
NCT06118099
Ethics application status
Date submitted
31/10/2023
Date registered
7/11/2023
Date last updated
22/10/2024

Titles & IDs
Public title
Proof-of-concept Study Evaluating Subcutaneous Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Secondary ID [1] 0 0
U1111-1290-9497
Secondary ID [2] 0 0
ACT17967
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Placebo

Experimental: Amlitelimab - Subcutaneous injection (SC) as per protocol.

Placebo comparator: Placebo - Subcutaneous injection as per protocol.


Treatment: Drugs: Amlitelimab
Injection solution SC injection

Treatment: Drugs: Placebo
Injection solution SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The clinical response as measured by the percentage of participants achieving HiSCR50 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Time to onset of achieving HiSCR50
Timepoint [1] 0 0
From baseline to Week 16
Secondary outcome [2] 0 0
Absolute change from baseline in AN count at Week 16
Timepoint [2] 0 0
Baseline to Week 16
Secondary outcome [3] 0 0
Percentage change in AN count at Week 16
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Percentage of participants achieving HiSCR75 at Week 16
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of participants achieving HiSCR90 at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of participants who experience improvement by at least 1 International Hidradenitis Suppurativa Severity Score System (IHS4) stage at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change in absolute score from Baseline in IHS4 at Week 16
Timepoint [7] 0 0
Baseline to Week 16
Secondary outcome [8] 0 0
Percentage of participants who experience a flare at Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Percentage of participants achieving IHS4-55 at Week 16
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Percentage of participants who experience 5-point reduction in DLQI at Week 16 among participants with baseline DLQI =4
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
Change from Baseline in the total Hidradenitis Suppurativa Quality of Life (HiSQOL) score at Week 16
Timepoint [13] 0 0
Baseline to Week 16
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline up to Week 116
Secondary outcome [15] 0 0
Incidence of potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms in the Safety Population
Timepoint [15] 0 0
Baseline up to Week 116
Secondary outcome [16] 0 0
Serum amlitelimab concentrations measured at prespecified time points in the PK population
Timepoint [16] 0 0
Day 1 up to Week 116
Secondary outcome [17] 0 0
Incidence of antidrug antibodies (ADA) of amlitelimab at prespecified timepoints in the ADA population
Timepoint [17] 0 0
Day 1 up to Week 116

Eligibility
Key inclusion criteria
* 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.
* Participants with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
* 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.
* Participant must have had an inadequate response to at least a 12-week trial of an oral antibiotic for treatment of HS
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)
* Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/01/2027
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - Phillip
Recruitment hospital [2] 0 0
Investigational Site Number : 0360001 - Darlinghurst
Recruitment hospital [3] 0 0
Investigational Site Number : 0360002 - Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Chile
State/province [11] 0 0
Reg Metropolitana De Santiago
Country [12] 0 0
France
State/province [12] 0 0
La Rochelle
Country [13] 0 0
France
State/province [13] 0 0
Lyon
Country [14] 0 0
France
State/province [14] 0 0
Reims
Country [15] 0 0
France
State/province [15] 0 0
Rouen
Country [16] 0 0
France
State/province [16] 0 0
Saint Mande
Country [17] 0 0
Germany
State/province [17] 0 0
Bochum
Country [18] 0 0
Germany
State/province [18] 0 0
Münster
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Hungary
State/province [20] 0 0
Debrecen
Country [21] 0 0
Hungary
State/province [21] 0 0
Szeged
Country [22] 0 0
Italy
State/province [22] 0 0
Catania
Country [23] 0 0
Italy
State/province [23] 0 0
Cona (Ferrara)
Country [24] 0 0
Poland
State/province [24] 0 0
Mazowieckie
Country [25] 0 0
Poland
State/province [25] 0 0
Warszawa
Country [26] 0 0
Poland
State/province [26] 0 0
Wroclaw
Country [27] 0 0
Portugal
State/province [27] 0 0
Lisboa
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona [Barcelona]
Country [29] 0 0
Spain
State/province [29] 0 0
Catalunya [Cataluña]
Country [30] 0 0
Spain
State/province [30] 0 0
Las Palmas
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid, Comunidad De

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational, placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and biological effects of treatment of subcutaneous injection of amlitelimab compared with placebo in male and female participants aged 18 to 70 years with moderate to severe hidradenitis suppurativa (HS).

The purpose of this study is to measure standardized clinician reported and participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An optional long-term extension (LTE) period will assess chronic safety and efficacy over an additional 80 weeks of amlitelimab treatment.

Study details include:

* The study duration will be up to 116 weeks, including a 4-week Screening period, a 16-week double-blind treatment period (DBT), an optional 80-week LTE period and a 16-week post-treatment follow-up period.
* All participants who complete the 16-week DBT period will be offered entry into an optional LTE.
* Participants who do not wish to enter the optional LTE period or who stop treatment prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP) administration prior to completing the LTE period will proceed into the 16-week post-treatment follow-up period.
* The number of planned in clinic visits will be up to six during the DBT period with an additional nine during the LTE period, plus one post-treatment follow-up end-of-study visit. Up to 11 optional in clinic visits are allowed for participants who do not wish to self-administer IMP between scheduled in clinic visits during the LTE period.
Trial website
https://clinicaltrials.gov/study/NCT06118099
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06118099