Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
317
Countries
3
Sites
20
Moderate to Severe Hidradenitis Suppurativa
To test if eltrekibart is superior to placebo in inducing Hidradenitis Suppurativa Clinical Response (HiSCR50) in adult participants with moderate-to-severe HS
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 4 Jul 2024 → ongoing
- Decision date (initial)
- 2024-06-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Eli Lilly and Company
External identifiers
- EU CT number
- 2023-505608-43-00
- WHO UTN
- U1111-1292-6255
- ClinicalTrials.gov
- NCT06046729
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacokinetic, Efficacy, Pharmacodynamic
To test if eltrekibart is superior to placebo in inducing Hidradenitis Suppurativa Clinical Response (HiSCR50) in adult participants 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 1
- 1. Have a diagnosis of HS for at least 12 months. 2. Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be Hurley Stage II or III. 3. Have an (abscess plus inflammatory nodule) count of at least 5. 4. Agree to use topical antiseptics daily. 5. Had an inadequate response or intolerance to a 28-day course of oral antibiotics.
Exclusion criteria 1
- 1. Have more than 20 draining fistulae. 2. Have had surgical treatment for HS in the last 4 weeks before randomization. 3. Have an active skin disease or condition, that could interfere with the assessment of HS. 4. Have a current or recent acute, active infection. 5. Are immunocompromised. 6. Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Time Frame: Week 16]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10980677 · Product
- Active substance
- Humanised IGG4 Kappa Monoclonal Antibody Against CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 and CXCL8
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 50 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Charles River Laboratories Montreal ULC ORG-100041009
|
Senneville, Canada | Other, Laboratory analysis |
| Eurofins Viracor Biopharma Services LLC ORG-100041736
|
Lenexa, United States | Other, Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other, Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| PPD Global Central Labs LLC ORG-100056706
|
Covington, United States | Other |
| Jumo Health USA Inc. ORG-100044054
|
New Haven, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 11, Code 12, Code 13, Code 2, Laboratory analysis, Code 5, Data management, E-data capture, Code 8 |
| Pra International ORG-100032850
|
Lenexa, United States | Other, Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Other, Laboratory analysis |
| Empatica Inc. ORG-100044397
|
Cambridge, United States | E-data capture |
Locations
3 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 37 | 8 |
| Greece | Ongoing, recruitment ended | 20 | 4 |
| Poland | Ongoing, recruitment ended | 33 | 8 |
| Rest of world
Australia, United States, Canada
|
— | 227 | — |
Investigational sites
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Dermatologische Gemeinschaftspraxis Mahlow, Am Bahnhof 1, Mahlow, Blankenfelde-Mahlow
Universitaetsklinikum Erlangen AöR
Hautklinik, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Bonn AöR
Klinik für Dermatologie und Allergologie, Zentrum für Hauterkrankungen,Klinisches Studienzentrum, Venusberg-Campus 1, Venusberg, Bonn
Goethe University Frankfurt
Klinische Forschung, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
St. Josef-Hospital
Dermatologische Studienambulanz, Gudrunstrasse 56, Grumme, Bochum
Universitaet Muenster
Klinik für Hautkrankheiten, Universitätsklinikum Münster (UKM), Von-Esmarch-Strasse 58, Sentrup, Muenster
University Medical Center Hamburg-Eppendorf
Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP), Martinistrasse 52, Eppendorf, Hamburg
Hautzentrum Friedrichshein
N/A, Frankfurter Allee 100, 10247, Berlin
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
1st Department of Dermatology and Venereology, Dragoumi Ionos 5 I, 161 21, Athens
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
General Department of Dermatology and Venereology, Dragoumi Ionos 5 I, 161 21, Athens
General Hospital Of Thessaloniki Papageorgiou
B’ clinic of skin and venereal diseases, Ring Road of Thessaloniki, Ministry Of Pavlos Melas, Thessaloniki
University General Hospital Of Heraklion
Dermatology Department, Voutes, 71110, Heraklion
NZOZ Labderm s.c.
n/a, ul. Leśna 2A, 42-624, Ossy
Dermoklinika-Medyczne Centrum s.c.
n/a, Al. Tadeusza Kościuszki 93, 90-436, Łódź
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
n/a, Ul. Ul. Sliczna 13, 50-566, Wroclaw
Uniwersyteckie Centrum Kliniczne
N/A, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Pratia S.A.
N/A, Ul. Dabrowki 13, 40-081, Katowice
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
N/A, Ul. Marii Konopnickiej 4, 82-200, Malbork
Wromedica I Bielicka A Strzalkowska s.c.
N/A, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
n/a, Ul. Woloska 137, 02-507, Warsaw
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-07-05 | 2024-10-28 | 2025-06-11 | ||
| Greece | 2024-07-19 | 2024-10-09 | 2025-06-11 | ||
| Poland | 2024-07-04 | 2024-07-17 | 2025-06-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 49 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Eli Lilly_I7P_MC_DSAF_2023_505608_43_00_Protocol_ENG_Initial_Public | N/A |
| Protocol (for publication) | D1_Eli Lilly_I7P_MC_DSAF_2023_505608_43_00_Protocol_GR_Initial_Public | N/A |
| Protocol (for publication) | D3_Eli Lilly_I7P_MC_DSAF_2023_505608_43_00_AverageSkinPainNRS_CopyrightMemo_Public | 1 |
| Recruitment arrangements (for publication) | K1_I7P-MC_DSAF_Recruitment_Informed_Consent_Procedure_PL_Polish_Public_placeholder | 2.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAF_Recruitment-Arrangements_DE_English_Public | n/a |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAF_Recruitment-Arrangements_GRC_English_Public | 1.2 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_FlipChart_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_Multifold_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_Ring_Cards_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_Study_Appointment_Card_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_Study_Discussion_Guide_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_Study_HCP_Refferal_Letter_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_Study_Thank_You_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7-MC-DSAF_Trifold_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF _Study-Recruitment Poster_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF Study-Thank You_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_FlipChart_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_GP-Letter_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Multifold_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Multifold_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Ring Cards_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Ring Cards_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study Appointment Card_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study Discussion Guide_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study Thank You_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study_Recruitment_Poster_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study-Appointment-Card_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study-Discussion Guide_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study-HCP Referral Letter_DE-German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study-HCP Referral Letter_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Study-Recruitment Poster_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Trifold_DE_German_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAF_Trifold_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2-I7P-MC-DSAF_FlipChart_DE_German_Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Main ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Main ICF_GRC_Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Main_ ICF_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Main_ICF_PL_Ukrainian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Main-ICF_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Pregnant Partner-Participant and newborn_ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Pregnant Partner-Participant and newborn_ICF_GRC_Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Pregnant_ Partner_ Consent_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Pregnant_ Partner_ Consent_PL_Ukrainian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Pregnant-Participant-ICF_DE_German_Public | 1 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAF_Pregnant-Partner-ICF_DE_German_Public | 1 |
| Synopsis of the protocol (for publication) | D2_Eli Lilly_I7P-MC-DSAF_2023_505608_43_00_Protocol Synopsis_ENG_Public | 1 |
| Synopsis of the protocol (for publication) | D2_Eli Lilly_I7P-MC-DSAF_2023_505608_43_00_Protocol Synopsis_GER_Public | 1 |
| Synopsis of the protocol (for publication) | D2_Eli Lilly_I7P-MC-DSAF_2023_505608_43_00_Protocol Synopsis_GRE_Public | 1 |
| Synopsis of the protocol (for publication) | D2_Eli Lilly_I7P-MC-DSAF_2023_505608_43_00_Protocol Synopsis_POL_Public | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-28 | Germany | Acceptable 2024-06-14
|
2024-06-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-27 | Germany | Acceptable 2024-06-14
|
2024-06-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-17 | Acceptable | 2024-09-26 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-24 | Germany | Acceptable | 2025-03-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-24 | Germany | Acceptable | 2026-03-24 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-31 | Germany | Acceptable | 2026-03-31 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-04-01 | Germany | Acceptable | 2026-04-01 |