Clinical trial • Phase III • Immunology|Dermatology

SONELOKIMAB for Hidradenitis suppurativa

Phase III trial of SONELOKIMAB for Hidradenitis suppurativa.

Overview

Trial Therapeutic Area
Immunology|Dermatology
Trial Disease
Hidradenitis suppurativa
Trial Stage
Phase III
Drug Modality
Other antibody

Key dates

Initial CTIS Submission Date
10-05-2024
First CTIS Authorization Date
02-09-2024

Trial design

Randomised, arm 1 - sonelokimab: sonelokimab 120 mg subcutaneous; 120 mg q2w from weeks 0-6 then 120 mg q4w starting at week 8. part b: continue sonelokimab 120 mg q4w from week 16 up to week 48 (with placebo doses at weeks 18 and 22 to maintain the blind). arm 2 - placebo: placebo (sterile solution in single use prefilled syringe for subcutaneous administration) q2w from weeks 0-6 then q4w starting at week 8. part b: participants will receive sonelokimab 120 mg q2w for 4 doses from weeks 16-22 then q4w from week 24 up to week 48.-controlled Phase III trial in Austria, Hungary, Poland and others.

Randomised
Yes
Comparator
Arm 1 - sonelokimab: sonelokimab 120 mg subcutaneous; 120 mg Q2W from Weeks 0-6 then 120 mg Q4W starting at Week 8. Part B: continue sonelokimab 120 mg Q4W from Week 16 up to Week 48 (with placebo doses at Weeks 18 and 22 to maintain the blind). Arm 2 - placebo: placebo (sterile solution in single use prefilled syringe for subcutaneous administration) Q2W from Weeks 0-6 then Q4W starting at Week 8. Part B: participants will receive sonelokimab 120 mg Q2W for 4 doses from Weeks 16-22 then Q4W from Week 24 up to Week 48.
Target Sample Size
138
Trial Duration For Participant
364

Stratification factors

  • Hurley Stage status (II and III)
  • Prior biologic use (Yes/No)
  • Geographic region

Eligibility

Recruits 138 Vulnerable population not selected (isVulnerablePopulationSelected=false). Participants must be adults (≥18 years) and "must be capable of giving signed informed consent as described in Appendix 1," so consent must be provided by the participant (no assent procedures for minors are applicable). Multiple language informed consent documents are available (see public ICF documents), and participants must comply with ICF requirements..

Pregnancy Exclusion
5. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if WOCBP) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test at screening and a negative urine pregnancy test at Week 0/Day 1 before initiation of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment. See Appendix 4 for the definition of nonchildbearing potential, childbearing potential, and highly effective methods of contraception.
Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false). Participants must be adults (≥18 years) and "must be capable of giving signed informed consent as described in Appendix 1," so consent must be provided by the participant (no assent procedures for minors are applicable). Multiple language informed consent documents are available (see public ICF documents), and participants must comply with ICF requirements.

Inclusion criteria

  • {"criterion_text":"- 1. Participants must be at least 18 years of age at the time of signing the informed consent\n- 2. Participants must complete at least 4 out of 7 days of eDiary entries in at least 1 of the 2 weeks before randomization.\n- 3. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator’s opinion. Typical duration of treatment before an inadequate response is declared should be no less than 8 to 12 weeks in accordance with to the recommendations in US and European guidelines.\n- 4. Participants enrolling in the antibiotic cohort must be on a stable dose (defined as a dose or dose regimen that has not changed in the previous 28 days before the initiation of study treatment).\n- 5. Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if WOCBP) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test at screening and a negative urine pregnancy test at Week 0/Day 1 before initiation of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment. See Appendix 4 for the definition of nonchildbearing potential, childbearing potential, and highly effective methods of contraception.\n- 6. Male participants must be willing to use a condom when sexually active with a WOCBP partner during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.\n- 7. Participants must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n- 8. Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent."}

Exclusion criteria

  • {"criterion_text":"- 1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.\n- 10. Participants who are enrolled in another interventional investigational study for a device or drug or have been so enrolled in the last 28 days before the initiation of study treatment or within 5 half-lives of the investigational study drug before the initiation of study treatment, whichever is longer.\n- 11. Participants with clinically significant electrocardiogram (ECG) abnormalities on centrally read ECG at the Screening Visit. Clinically significant ECG abnormalities are considered changes that often indicate underlying cardiac conditions that may require immediate medical attention.\n- 12. Participants with laboratory abnormalities at the Screening Visit, including any of the following:a.\tAspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3× upper limit of normal (ULN). b.\tSerum direct bilirubin >1.5×ULN (in the absence of known Gilbert syndrome). c.\tWhite blood cell count <3×10^9/L. d.\tAbsolute neutrophil count <1.5×10^9/L. e.\tAbsolute lymphocyte count <0.7×10^9/L. f.\tPlatelet count <100×10^9/L. g.\tHemoglobin <85 g/L. h.\tCreatinine clearance <30 mL/min (by Cockcroft Gault formula).\n- 13. Any other laboratory abnormality which, in the opinion of the investigator, might compromise participant’s safety, prevent the participant from completing the study or would interfere with the interpretation of the study results.\n- 14. Participants who have had major surgery (e.g., hip replacement, aneurysm removal) within 6 months before the initiation of study treatment or are planning to have major surgery during the study.\n- 15. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.\n- 16. Participants who have a history of chronic alcohol or drug abuse in the past year before the Screening Visit\n- 17. Participants who are an employee or a direct relative of an employee of the sponsor, a study center, or a third-party organization involved in the study.\n- 18. Participants with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, or cardiac) that, in the opinion of the investigator, potentially places the participant at unacceptable risk.\n- 19. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk, including any medical or psychiatric condition that, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.\n- 2. Participants with evidence of tuberculosis (TB) infection (active, history of active, latent or history of latent) at the Screening Visit. Participants may still enter the study if they have documented evidence that they have completed sufficient treatment, according to local routine clinical practice, at least 4 weeks before randomization. If they completed their treatment at least 4 weeks before and within 24 months of the Baseline Visit, to be enrolled they need to have documented evidence of treatment and have no evidence of active or latent disease. If they completed their treatment over 24 months before baseline, to be enrolled they need to have been adequately treated and confirmed to be fully recovered upon consultation with a TB specialist (see Section 8.1.3).\n- 20. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS, prevent participants from complying with protocol requirements (including the requirement for prohibited medications), or put the participant at undue risk.\n- 21. Participants with a confirmed or suspected diagnosis of inflammatory bowel disease (eg, ulcerative colitis or Crohn’s disease), either in medical history or currently present. Note: participants with functional gastrointestinal disorders (eg, irritable bowel syndrome) can be considered eligible for enrolment if inflammatory bowel disease has been excluded and documented (eg, formal clinical criteria, endoscopy, fecal calprotectin stool test).\n- 22. Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the initiation of study treatment.\n- 23. Participants with an active infection or history of infections including any of the following: a. Any infection (exception: common cold) requiring systemic anti-infective treatment within 14 days before initiation of study treatment. b. Serious infection, defined as requiring hospitalization or intravenous anti-infectives, within 2 months before initiation of study treatment. c. Candida infection requiring systemic therapy for ≥7 days in the last 12 months before initiation of study treatment. d. Previous esophageal or systemic candidiasis. e. Current active candidiasis or Candida infection within the last 3 months before the initiation of study treatment.\n- 3. Participants with any current nontuberculous mycobacterial infection or any history of nontuberculous mycobacterial infection at the Screening Visit.\n- 4. Participants with a concurrent acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the Screening Visit.\n- 5. Participants with evidence of human immunodeficiency virus (HIV) infection at the Screening Visit.\n- 6. Participants with a concurrent malignancy or a history of malignancy within 5 years of the initiation of study treatment with the following exceptions: a. Three or fewer successfully excised or ablated basal cell carcinomas of the skin. b. One squamous cell carcinoma of the skin not worse than Stage T1 that has been successfully treated, with no signs of recurrence or metastases for at least the past 2 years before study treatment initiation. c. Actinic keratosis. d. Squamous cell carcinoma in situ of the skin successfully treated >6 months before study treatment initiation. e. Localized carcinoma in situ of the cervix treated and considered cured.\n- 7. Participants with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.\n- 8. Participants with primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants.\n- 9. Participants who currently use or plan to use one or more prohibited treatments specified in this protocol unless permitted according to criteria in Section 6.9.1, including high-potency opioid analgesics [eg, methadone, hydromorphone, or morphine], GLP-1 analogs, or ongoing use of prohibited HS treatments/medications [eg, systemic or topical corticosteroids] at baseline)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percentage of participants achieving HiSCR75 score at Week 16","definition_or_measurement_approach":"Measured as the percentage of participants who achieve HiSCR75 at Week 16 (HiSCR75 response at Week 16 as specified in the protocol)."}

Secondary endpoints

  • {"endpoint_text":"- 6. Treatment-emergent adverse event (TEAEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 7. SAEs","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 8. TEAEs leading to study withdrawal","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 9. Adverse event of special interest (AESIs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 10. Physical examinations, vital signs, and ECG results","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 11. Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 1. Percentage of participants achieving HiSCR50 at Week 16.","definition_or_measurement_approach":"Measured as the percentage of participants achieving HiSCR50 at Week 16."}
  • {"endpoint_text":"- 4. Absolute change in HiSQOL score at Week 16","definition_or_measurement_approach":"Measured as absolute change from baseline to Week 16 in HiSQOL score."}
  • {"endpoint_text":"- 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4 .","definition_or_measurement_approach":"Calculated as percentage of participants with baseline DLQI ≥4 who have DLQI total reduction ≥4 at Week 16."}
  • {"endpoint_text":"- 2. Percentage of participants achieving IHS4-55 at Week 16.","definition_or_measurement_approach":"Measured as percentage of participants achieving IHS4‑55 at Week 16."}
  • {"endpoint_text":"- 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for pain in PGA among participants with a baseline NRS ≥3","definition_or_measurement_approach":"Measured as percentage of participants with baseline NRS ≥3 who achieve ≥3‑unit reduction in NRS for pain in PGA at Week 16."}

Recruitment

Planned Sample Size
138
Recruitment Window Months
19
Consent Approach
Informed consent must be provided in writing by the participant (adults only). The protocol states participants "must be capable of giving signed informed consent as described in Appendix 1." Multiple language versions of the ICF and subject information are provided (documents list includes language-specific ICFs: en, bg, hu, pl, pt, it, de, no, etc.). No assent for minors is applicable because only adults (≥18) are eligible.

Methods

  • K2_Poster / recruitment posters (document titles: K2_Poster, K2_Recruit-Poster) - site/poster recruitment materials
  • K2_Recruit-Brochure / recruitment brochures (document titles: K2_Recruit-Brochure, K2_Recruit Brochure) - printed recruitment material
  • K2_Recruit-SVG / K2_SVG - graphic recruitment assets
  • K2_GP Letter - letter to general practitioners to support recruitment
  • K2_Study Visit Guide - study visit guidance for participants
  • K1_Recruit-ICF Process / K1_Recruit-ICF Process_FP - recruitment / ICF process documents

Geography

Total Number Of Sites
57
Total Number Of Participants
262

Austria

Earliest CTIS Part Ii Submission Date
07-08-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
26
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Dermatologie Abteilung für Allgemeine Dermatologie
Contact Person Name
Constanze Jonak

Hungary

Earliest CTIS Part Ii Submission Date
05-07-2024
Latest Decision Or Authorization Date
03-09-2024
Processing Time Days
60
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
University Of Debrecen
Department Name
Bőrgyógyászati Klinika
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
University Of Pecs
Department Name
Bőr-, Nemikórtani és Onkodermatológiai Klinika
Contact Person Name
Zsuzsanna Lengyel
Contact Person Email
lengyel.zsuzsanna@pte.hu
Site Name
Derma-B Kft.
Contact Person Name
Emese Herédi
Contact Person Email
emeseheredi@gmail.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Contact Person Name
Beáta Bakos
Contact Person Email
beata.bakos@oec.hu

Poland

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
04-09-2024
Processing Time Days
33
Number Of Sites
15
Number Of Participants
80

Sites

Site Name
"Dermoklinika-Centrum Medyczne" Spółka Cywilna M.Kierstan, J.Narbutt, A.Lesiak
Contact Person Name
Aleksandra Lesiak
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Dermatologii, Wenerologii i Alergologii
Contact Person Name
Roman Nowicki
Contact Person Email
dermatologia@uck.gda.pl
Site Name
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczny Ośrodek Dermatologiczny "Dermal"
Contact Person Name
Adam Wroński
Contact Person Email
bk@dermal.pl
Site Name
Dermed Centrum Medyczne Sp. z o.o.
Department Name
Niepubliczny Zakład Opieki Zdrowotnej "DERMED" Centrum Medyczne
Contact Person Name
Aleksandra Kaszuba
Contact Person Email
akaszuba@op.pl
Site Name
Specjalistyczny gabinet dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paweł Brzewski s.c.
Contact Person Name
Paweł Brzewski
Contact Person Email
brzewski@sgd-polska.com
Site Name
Dermmedica Sp. z o.o.
Department Name
Centrum Columbus
Contact Person Name
Jolanta Węglowska
Contact Person Email
office@dermmedica.pl
Site Name
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Department Name
CENTRUM ZDROWIA DZIECKA I RODZINY IM. JANA PAWŁA II W SOSNOWCU - OŚRODEK BADAŃ KLINICZNYCH
Contact Person Name
Hubert Arasiewicz
Contact Person Email
badania-kliniczne@czdir.pl
Site Name
Luxderm Specjalistyczny Gabinet Dermatologiczny Prof.Dr Hab.N.Med.Dorota Krasowska
Contact Person Name
Dorota Krasowska
Contact Person Email
gabinetluxderm@gmail.com
Site Name
Solumed Sp. z o.o. sp.k.
Department Name
Solumed Centrum Medyczne
Contact Person Name
Kinga Adamska
Contact Person Email
clinicaltrials@solumed.pl
Site Name
Labderm Essence Sp. z o.o.
Department Name
Niepubliczny Zakład Opieki Zdrowotnej Labderm S.C.
Contact Person Name
Beata Bergler-Czop
Contact Person Email
biuro@labderm.pl
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
Twoja Przychodnia SCM
Contact Person Name
Tadeusz Dębniak
Contact Person Email
hanza@twojaprzychodnia.com
Site Name
Royalderm Agnieszka Nawrocka
Contact Person Name
Witold Owczarek
Contact Person Email
kontakt@royalderm.pl
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Contact Person Name
Mariusz Sikora
Contact Person Email
g.fiutkowski@clinicalbs.com
Site Name
Pratia S.A.
Department Name
PRATIA MCM KRAKÓW
Contact Person Name
Dorota Kołodziejczyk
Contact Person Email
biuro.mcm@pratia.com
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Dermatologii
Contact Person Name
Irena Walecka-Herniczek
Contact Person Email
dermatologia@cskmswia.gov.pl

Portugal

Earliest CTIS Part Ii Submission Date
23-07-2024
Latest Decision Or Authorization Date
03-09-2024
Processing Time Days
42
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Dermatovenereology
Contact Person Name
Inês Lobo
Site Name
Unidade Local De Saude De Sao Jose E.P.E.
Department Name
Dermatology
Contact Person Name
Joana Cabete
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Dermatology
Contact Person Name
Joana Antunes

Italy

Earliest CTIS Part Ii Submission Date
09-07-2024
Latest Decision Or Authorization Date
03-09-2024
Processing Time Days
56
Number Of Sites
14
Number Of Participants
56

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Dermatology Unit
Contact Person Name
Marco Romanelli
Contact Person Email
marco.romanelli@unipi.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Dipartimento Di Medicina E Chirurgia
Contact Person Name
Luca Stingeni
Contact Person Email
luca.stingeni@unipg.it
Site Name
Universita' Degli Studi Di Ferrara
Department Name
UOC Dermatologia
Contact Person Name
Natale Schettini
Contact Person Email
natale.schettini@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dermatology Unit
Contact Person Name
Angelo Valerio Marzano
Contact Person Email
angelo.marzano@unimi.it
Site Name
Azienda USL Toscana Centro
Department Name
Dipartimento di Scienze della Salute (DSS
Contact Person Name
Francesca Prignano
Contact Person Email
francesca.prignano@unifi.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Dermatology Unit
Contact Person Name
Antonio Costanzo
Contact Person Email
antonio.costanzo@hunimed.edu
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Unità Operativa Dermatologia
Contact Person Name
Marco Manfredini
Contact Person Email
marco.manfredini@unimore.it
Site Name
Universita' Degli Studi G. D'annunzio Di Chieti
Department Name
Centro di Ricerca Clinica (CRC) del Centro Studi e Tecnologie Avanzate
Contact Person Name
Paolo Amerio
Contact Person Email
p.amerio@unich.it
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOSD Clinica Dermatologica
Contact Person Name
Anna Balato
Contact Person Email
anna.balato@unicampania.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica Dermatologica
Contact Person Name
Oriana Simonetti
Site Name
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dermatology Department
Contact Person Name
Simone Ribero
Contact Person Email
simone.ribero@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Dermatology Unit
Contact Person Name
Piergiacomo Calzavara Pinton
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dermatology Unit
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
Dermatology Unit
Contact Person Name
Giuseppe Micali
Contact Person Email
giuseppe.micali@unict.it

Norway

Earliest CTIS Part Ii Submission Date
21-08-2024
Latest Decision Or Authorization Date
02-09-2024
Processing Time Days
12
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Oslo University Hospital HF
Department Name
Dermatology
Contact Person Name
Olav Sundnes
Contact Person Email
olasun@ous-hf.no

Bulgaria

Earliest CTIS Part Ii Submission Date
22-08-2024
Latest Decision Or Authorization Date
03-09-2024
Processing Time Days
12
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Military Medical Academy
Department Name
Clinic of Dermatology and Venerology
Contact Person Name
Vessel Kantardjiev
Contact Person Email
v.kantarjiev@vma.bg
Site Name
ASMC IPSMC Skin And Venereal Diseases
Contact Person Name
Ivan Botev
Contact Person Email
botev2@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Clinic of Skin and Venereal Diseases
Contact Person Name
Dimitar Gospodinov
Contact Person Email
dkg@abv.bg
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Clinic of Medical Oncology
Contact Person Name
Petranka Kaneva – Troyanova

Germany

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
04-09-2024
Processing Time Days
30
Number Of Sites
15
Number Of Participants
63

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik
Contact Person Name
Michael Sticherling
Site Name
Hautaerzte Zentrum Hannover GbR
Contact Person Name
Florian Schenck
Contact Person Email
schenck@hautaerzte-zentrum.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Dermatologie und Venerologie
Contact Person Name
Johannes Wohlrab
Site Name
Praxis Dr. med Abdou Zarzour
Contact Person Name
Abdou Zarzour
Contact Person Email
zarzour@gmx.de
Site Name
ISA Interdisciplinary Study Association GmbH
Contact Person Name
Margrit Simon
Contact Person Email
msimon@isa-research.de
Site Name
Klinikum Oldenburg AöR
Department Name
Universitätsklinik für Dermatologie und Allergologie
Contact Person Name
Nikolaos Patsinakidis
Site Name
Beldio Research GmbH
Contact Person Name
Andreas Schwinn
Contact Person Email
schwinn@beldio.com
Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Dr. Niesmann And Dr. Othlinghaus GbR
Contact Person Name
Johannes Niesmann
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Dermatology
Contact Person Name
Frederik Krefting
Contact Person Email
frederik.krefting@uk-essen.de
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Department of Dermatology, Allergology and Dermatosurgery
Contact Person Name
Galina Balakirski
Contact Person Email
WUP-DERMA@helios-gesundheit.de
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Pinter
Contact Person Email
andreas.pinter@pinter-med.com
Site Name
Studienzentrum Dr. Beate Schwarz
Department Name
Dermatology
Contact Person Name
Beate Schwarz
Contact Person Email
studie@hautarzt-langenau.de
Site Name
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Contact Person Name
Michael Sebastian
Contact Person Email
m.sebastian@derma-mahlow.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Department of Dermatology
Contact Person Name
Norman-Philipp Hoff

Sponsor

Primary sponsor

Full Name
MoonLake Immunotherapeutics AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple sponsor duties (codes listed in CTIS; contact: ctisapplications-pharma@iconplc.com)
Name
QPS LLC
Responsibilities
PK and ADA
Name
Medidata Solutions Inc.
Responsibilities
Platform/services (sponsor duty code 7 as provided)
Name
Eresearchtechnology Inc.
Responsibilities
eCOA and ECG services
Name
Olink Proteomics AB
Responsibilities
Serum biomarkers

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,12,2,5,6 (as listed in CTIS)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"PK and ADA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA and ECG services","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Olink Proteomics AB","duties_or_roles":"Serum biomarkers","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Sonelokimab
Active Substance
SONELOKIMAB
Modality
Other antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous injection
Starting Dose
120 mg
Dose Levels
120 mg
Frequency
120 mg Q2W (Weeks 0-6) then 120 mg Q4W starting Week 8; Part B dosing as specified in protocol
Maximum Dose
120 mg
Investigational Product Name
Placebo is a sterile solution in a single use prefilled syringe (PFS) intended for subcutaneous administration
Modality
Other
Routes Of Administration
Subcutaneous (intended)
Route
Subcutaneous injection (PFS)
Frequency
Q2W (Weeks 0-6) then Q4W starting Week 8 per protocol for placebo arm

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