Dose-response Relationship Study of S42909 on Leg Ulcer Healing

NCT03077165 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CL2-42909-016
• Study Type: interventional
• Target: 121
• Locations: 11 countries
• Sites: 80

Brief Summary

Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Relative Reduction of Reference Ulcer Area After 4 Weeks of Treatment on Top of Standard of Care Compared With Baseline Reference Ulcer Area (W000) Assessed During Study Visits

  Change of reference Ulcer area measurement in cm\^2 from Baseline to Week 4.

  Baseline and Week 4

Secondary Outcomes (2)

• Adverse Events

  Up to 8 weeks

• Assessment of Laboratory Parameters

  Up to 8 weeks

Study Arms (6)

Group A

EXPERIMENTAL

S42909 dose 100 mg p.o., 50 mg bid

Drug: S42909 100 mg

Group B

EXPERIMENTAL

S42909 dose 200 mg p.o., 100 mg bid

Drug: S42909 200 mg

Group C

EXPERIMENTAL

S42909 dose 400 mg p.o., 200 mg bid

Drug: S42909 400 mg

Group D

EXPERIMENTAL

S42909 dose 800 mg p.o., 400 mg bid

Drug: S42909 800 mg

Group E

EXPERIMENTAL

S42909 dose 1200 mg p.o., 600 mg bid

Drug: S42909 1200 mg

Group F

PLACEBO COMPARATOR

Placebo p.o. bid

Drug: Placebo Oral Tablet

Interventions

S42909 100 mg DRUG

50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

Group A

S42909 200 mg DRUG

50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

Group B

S42909 400 mg DRUG

200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

Group C

S42909 800 mg DRUG

200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.

Group D

S42909 1200 mg DRUG

200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

Group E

Placebo Oral Tablet DRUG

Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.

Group F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian (defined for this study as having 2 Caucasian parents), men or women
• Age ≥ 18 years old
• kg/m2 ≤ BMI ≤ 45.0 kg/m2 (= Weight (kg) / height² (m²))
• Patients with chronic venous disease documented by imaging to detect a venous disorder in one or both the sub- and extra-fascial venous systems. The examination performed within 6 months before selection can be used.
• Patients with at least one active venous leg ulcer localised in the gaiter area (CEAP C6) diagnosed or reoccurred for more than 6 weeks and less than 2 years at selection and 3 cm away from other ulcers. Patients with bilateral ulcerations or multiple ulcerations on one or both legs are eligible for selection.
• Ankle Brachial Pressure Index (ABPI) ≥ 0.8 and ≤ 1.3 measured by Doppler ultrasound.

You may not qualify if:

• Unlikely or unwilling to be compliant to standardized compression recommendation, study medication and visits, previous records of poor compliance to compression stockings.
• Inadequately controlled type 1 and type 2 diabetes with an HbA1c \> 8%.

Sponsors & Collaborators

• Ilkos Therapeutic Inc.: lead

Study Sites (80)

ILD Research Center

Carlsbad, California, 92009, United States

Location

Center for Clinical Research Inc.

Carmichael, California, 95608, United States

Location

Center for Clinical Research Inc.

Castro Valley, California, 94546, United States

Location

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

Location

Foot and Ankle Clinic

Los Angeles, California, 90057, United States

Location

Stanford Hospitals and Clinics

Redwood City, California, 94063, United States

Location

Center for Clinical Research Inc.

San Francisco, California, 94115, United States

Location

University of Miami Hospital Wound Center

Miami, Florida, 33136, United States

Location

St. Luke's Intermountain Research Center

Boise, Idaho, 83702, United States

Location

Podiatry 1st

Belleville, Illinois, 62226, United States

Location

Advanced Foot & Ankle Center

Las Vegas, Nevada, 89119, United States

Location

The Snyder Institute for Vascular Health and Research

Kittanning, Pennsylvania, 16201, United States

Location

D&P Medical Group, LLC

Pittsburgh, Pennsylvania, 15219, United States

Location

Serena Group Research Foundation

Pittsburgh, Pennsylvania, 15219, United States

Location

Centro Dr Bottini de flebologia y estetica

Ciudad Autonoma de Buenos Aire, C1115AAE, Argentina

Location

Hospital Italiano de La Plata

La Plata, B1900AXI, Argentina

Location

DIM Clinica Privada

Ramos Mejía, B1704ETD, Argentina

Location

Sanatorio Mapaci

Rosario, 2000, Argentina

Location

Medizinische Universitaet Innsbruck Universitaetsklinik für Gefässchirurgie

Innsbruck, 6020, Austria

Location

VENEX Zentrum fuer minimal invasive Venentherapie

Vienna, 1080, Austria

Location

Medizinische Universitaet Wien AKH- Dermatologie

Vienna, 1090, Austria

Location

Faculdade de Medicina de Botucatu

Botucatu, 18618-686, Brazil

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-003, Brazil

Location

Faculdade de Medicina do ABC Cepes

Santo André, 09060-870, Brazil

Location

Centro Multidisciplinar de Estudos Clinicos CEMEC

São Bernardo do Campo, 09715-090, Brazil

Location

Hospital Sao Paulo

São Paulo, 04037-002, Brazil

Location

Hospital Sao Vicente de Paulo

Teixeira Soares, 99010-080, Brazil

Location

Alberta Health Services

Calgary, Alberta, T2R 0X7, Canada

Location

Parkwood Institute

London, Ontario, N6C 0A7, Canada

Location

Toronto Regional Dermatology & Wound Healing Clinic

Mississauga, Ontario, L4Y 1A6, Canada

Location

Ottawa Hospital Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Centrepoint Medical Center

Ottawa, Ontario, K2G 6E2, Canada

Location

York Dermatology Center

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

I. Dermatovenerologicka Klinika

Brno, 602 00, Czechia

Location

MATMED s.r.o.

Hodonín, 69501, Czechia

Location

Nemocnice Jihlava Chirurgie A

Jihlava, 586 33, Czechia

Location

Nemocnice Trebic Kozni oddeleni p.o.

Třebíč, 674 01, Czechia

Location

Angiocor s.r.o.

Zlín, 76001, Czechia

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Peterfy Sandor Utcai Korhaz

Budapest, 1076, Hungary

Location

Egyesitett Szent Istvan es Szent

Budapest, 1097, Hungary

Location

Bajcsy-Zsilinsky Korhaz

Budapest, 1106, Hungary

Location

Magyar Honvedseg Egeszsegugyi

Budapest, 1134, Hungary

Location

Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum

Debrecen, 4012, Hungary

Location

Bacs-Kiskun Megyei Korhaz

Kecskemét, 6000, Hungary

Location

Josa Andras Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Pesi Tudomanyegyetem Klnikai Kozpont

Pécs, 7632, Hungary

Location

Szegedi Tudomanyegyetem Borgyogyaszati es Allergologiai Klinica

Szeged, 6720, Hungary

Location

Azienda Ospedaliera San Giuseppe Moscati Medicina interna

Avellino, 83100, Italy

Location

Ospedale San Bassiano - Azienda ULSS n. 7 Pedemontana - Ambulatorio di Vulnologia

Bassano del Grappa, 36061, Italy

Location

Ospedale San Giacomo Apostolo Castelfranco Veneto - U.O. Angiologia

Castelfranco Veneto, 31033, Italy

Location

Policlinico Vittorio Emanuele - Presidio Ospedaliero Vittorio Emanuele

Catania, 95124, Italy

Location

Azienda Ospedaliero Universitaria di Padova U.O. Angiologia - Medicina Vascolare

Padua, 35128, Italy

Location

Istituto Neurologico Mediterraneo NEUROMED U.O.C. Chirurgia Vascolare ed Endovascolare

Pozzilli, 86077, Italy

Location

Ospedale Basso Ionio ASPCZ U.O.C. Chirurgia Generale, P.O. di Soverato

Soverato Marina, 88068, Italy

Location

Ospedale Belcolle - U.O Angiologia

Viterbo, 01100, Italy

Location

ClinicMed Daniluk

Bialystok, 15-879, Poland

Location

Szpital Uniwersytecki nr 1 im. Antoniego Jurasza

Bydgoszcz, 85-094, Poland

Location

Medical Academy of Lublin

Lublin, 20-081, Poland

Location

SP Szpital Kliniczny Nr1

Poznan, 60-848, Poland

Location

Klinika Flebologii

Warsaw, 02-034, Poland

Location

ALIAN, s.r.o., Poliklinika ČK plus

Bardejov, 085 01, Slovakia

Location

BeneDerma

Bratislava, 84102, Slovakia

Location

Derm-Therapy

Bratislava, 85101, Slovakia

Location

M.M.-Angio spol. s r.o., Angiologicka ambulancia

Dunajská Streda, 929 01, Slovakia

Location

ANGIOCARE, s.r.o.

Košice, 040 01, Slovakia

Location

ALIAN, s.r.o., Angiologická ambulancia

Poprad, 058 01, Slovakia

Location

Dermatovenerologicke oddelenie SANARE, spol. s r.o.

Svidník, 089 01, Slovakia

Location

Nemocnica arm. generala L. Svobodu Svidnik

Svidník, 08901, Slovakia

Location

MEDENA s.r.o., Angiologicka ambulancia

Trnava, 917 01, Slovakia

Location

MEDIVASA, s.r.o.

Žilina, 010 01, Slovakia

Location

Fundacion Hospital de Aviles

Avilés, 33402, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Consorci Sanitari de Terrassa - Hospital de Terrassa

Barcelona, 08227, Spain

Location

Hospital Universitario de Getafe

Getafe, 280902, Spain

Location

Hospital de la Cruz Roja de Madrid

Madrid, 28003, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Complejo Asistencial Universitario

Salamanca, 37007, Spain

Location

Hospital de Manises

Valencia, 46940, Spain

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Monique Champagne
• Organization: IlkosTherapeutic Inc.

mchampagne@ilkostherapeutic.com

450-680-3381

Study Officials

• Eberhard Rabe, Professor

  Department of Dermatology University of Bonn

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 10, 2017
• Study Start: September 12, 2017
• Primary Completion: December 12, 2019
• Study Completion: January 22, 2020
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CZ (5); IT (8); PL (5); ES (8); US (14); SL (10); HU (10); AR (4); BR (6); CA (7)