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Venous Leg UlcerPhase 2NCT03077165

Dose-response Relationship Study of S42909 on Leg Ulcer Healing

A Phase 2 study testing S42909 100 mg, S42909 200 mg and S42909 400 mg in people with Venous Leg Ulcer, run by Ilkos Therapeutic Inc. at 80 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Leg Ulcer
What is being tested?
S42909 100 mg, S42909 200 mg and S42909 400 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
80 sitesin 11 countries
Study dates
12 Sep 2017to 22 Jan 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Caucasian (defined for this study as having 2 Caucasian parents), men or women
  • Age ≥ 18 years old
  • 18.5 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.
  • Size of Reference Ulcer (defined as the largest ulcer in size that is fitting the area selection criteria) should be ≥ 5 cm2 and ≤ 100 cm2 at the selection visit and ≥ 4.5 cm2 and ≤ 100 cm2 at the inclusion visit (measured by transparent sheet and confirmed with the digital 3D imaging device).
  • Ankle Brachial Pressure Index (ABPI) ≥ 0.8 and ≤ 1.3 measured by Doppler ultrasound.

Who cannot join

  • 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%.

Trial locations and contacts

80 sites in 11 countries.

80 sites in 11 countries

United States14 sites

  • Podiatry 1st

    Belleville, Illinois, 62226

  • St. Luke's Intermountain Research Center

    Boise, Idaho, 83702

  • ILD Research Center

    Carlsbad, California, 92009

  • Center for Clinical Research Inc.

    Carmichael, California, 95608

  • Center for Clinical Research Inc.

    Castro Valley, California, 94546

  • Limb Preservation Platform, Inc.

    Fresno, California, 93710

  • The Snyder Institute for Vascular Health and Research

    Kittanning, Pennsylvania, 16201

  • Advanced Foot & Ankle Center

    Las Vegas, Nevada, 89119

  • Foot and Ankle Clinic

    Los Angeles, California, 90057

  • University of Miami Hospital Wound Center

    Miami, Florida, 33136

  • D&P Medical Group, LLC

    Pittsburgh, Pennsylvania, 15219

  • Serena Group Research Foundation

    Pittsburgh, Pennsylvania, 15219

  • Stanford Hospitals and Clinics

    Redwood City, California, 94063

  • Center for Clinical Research Inc.

    San Francisco, California, 94115

Other trials in United States

Hungary10 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Peterfy Sandor Utcai Korhaz

    Budapest, 1076

  • Egyesitett Szent Istvan es Szent

    Budapest, 1097

  • Bajcsy-Zsilinsky Korhaz

    Budapest, 1106

  • Magyar Honvedseg Egeszsegugyi

    Budapest, 1134

  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum

    Debrecen, 4012

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, 6000

  • Josa Andras Oktatokorhaz

    Nyíregyháza, 4400

  • Pesi Tudomanyegyetem Klnikai Kozpont

    Pécs, 7632

  • Szegedi Tudomanyegyetem Borgyogyaszati es Allergologiai Klinica

    Szeged, 6720

Other trials in Hungary

Slovakia10 sites

  • ALIAN, s.r.o., Poliklinika ČK plus

    Bardejov, 085 01

  • BeneDerma

    Bratislava, 84102

  • Derm-Therapy

    Bratislava, 85101

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

    Dunajská Streda, 929 01

  • ANGIOCARE, s.r.o.

    Košice, 040 01

  • ALIAN, s.r.o., Angiologická ambulancia

    Poprad, 058 01

  • Dermatovenerologicke oddelenie SANARE, spol. s r.o.

    Svidník, 089 01

  • Nemocnica arm. generala L. Svobodu Svidnik

    Svidník, 08901

  • MEDENA s.r.o., Angiologicka ambulancia

    Trnava, 917 01

  • MEDIVASA, s.r.o.

    Žilina, 010 01

Other trials in Slovakia

Italy8 sites

  • Azienda Ospedaliera San Giuseppe Moscati Medicina interna

    Avellino, 83100

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

    Bassano del Grappa, 36061

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

    Castelfranco Veneto, 31033

  • Policlinico Vittorio Emanuele - Presidio Ospedaliero Vittorio Emanuele

    Catania, 95124

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

    Padova, 35128

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

    Pozzilli, 86077

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

    Soverato Marina, 88068

  • Ospedale Belcolle - U.O Angiologia

    Viterbo, 01100

Other trials in Italy

Spain8 sites

  • Fundacion Hospital de Aviles

    Avilés, 33402

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Consorci Sanitari de Terrassa - Hospital de Terrassa

    Barcelona, 08227

  • Hospital Universitario de Getafe

    Getafe, 280902

  • Hospital de la Cruz Roja de Madrid

    Madrid, 28003

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Complejo Asistencial Universitario

    Salamanca, 37007

  • Hospital de Manises

    Valencia, 46940

Other trials in Spain

Canada7 sites

  • Alberta Health Services

    Calgary, Alberta, T2R 0X7

  • Parkwood Institute

    London, Ontario, N6C 0A7

  • Toronto Regional Dermatology & Wound Healing Clinic

    Mississauga, Ontario, L4Y 1A6

  • Ottawa Hospital Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • Centrepoint Medical Center

    Ottawa, Ontario, K2G 6E2

  • York Dermatology Center

    Richmond Hill, Ontario, L4C 9M7

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Brazil6 sites

  • Faculdade de Medicina de Botucatu

    Botucatu, 18618-686

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-003

  • Faculdade de Medicina do ABC Cepes

    Santo André, 09060-870

  • Centro Multidisciplinar de Estudos Clinicos CEMEC

    São Bernardo do Campo, 09715-090

  • Hospital Sao Paulo

    São Paulo, 04037-002

  • Hospital Sao Vicente de Paulo

    Teixeira Soares, 99010-080

Other trials in Brazil

Czechia5 sites

  • I. Dermatovenerologicka Klinika

    Brno, 602 00

  • MATMED s.r.o.

    Hodonín, 69501

  • Nemocnice Jihlava Chirurgie A

    Jihlava, 586 33

  • Nemocnice Trebic Kozni oddeleni p.o.

    Třebíč, 674 01

  • Angiocor s.r.o.

    Zlín, 76001

Other trials in Czechia

Poland5 sites

  • ClinicMed Daniluk

    Bialystok, 15-879

  • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza

    Bydgoszcz, 85-094

  • Medical Academy of Lublin

    Lublin, 20-081

  • SP Szpital Kliniczny Nr1

    Poznan, 60-848

  • Klinika Flebologii

    Warsaw, 02-034

Other trials in Poland

Argentina4 sites

  • Centro Dr Bottini de flebologia y estetica

    Ciudad Autonoma de Buenos Aire, C1115AAE

  • Hospital Italiano de La Plata

    La Plata, B1900AXI

  • DIM Clinica Privada

    Ramos Mejía, B1704ETD

  • Sanatorio Mapaci

    Rosario, 2000

Other trials in Argentina

Austria3 sites

  • Medizinische Universitaet Innsbruck Universitaetsklinik für Gefässchirurgie

    Innsbruck, 6020

  • VENEX Zentrum fuer minimal invasive Venentherapie

    Vienna, 1080

  • Medizinische Universitaet Wien AKH- Dermatologie

    Vienna, 1090

Other trials in Austria

About this study

Official title: A 10-week Randomized, Double-blind, Placebo-controlled, Prospective, International, Multicentre, Phase IIa Study of S42909 on Leg Ulcer Healing.

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

Read the detailed description

S42909 is an inhibitor of β-Nicotinamide Adenine Dinucleotide Phosphate (NADPH) oxidase which also inhibits vascular leukocyte adhesion to endothelial cells, Matrix Metalloproteinase-2 (MMP-2) and Plasminogen Activator Inhibitor-1 (PAI-1) activity. It is proposed for development in the treatment of venous and mixed leg ulcers.

This proof of concept study is a randomized, double-blind, placebo-controlled, multicenter, Phase IIa trial to evaluate the dose response of S42909 for the treatment of venous leg ulcers.

Patients suffering from chronic venous disease and having at least one active venous leg ulcer will be selected at the selection visit (ASSE). One Reference Ulcer (RU) defined as the largest ulcer in size that is fitting the area selection criteria will be established. At ASSE, a first picture will be taken before cleansing and debridement and a second picture will be taken after cleansing and debridement. The investigator will check that the selection RU area is compliant with the selection criteria. Patients will start the selection period and will be switched from their current pharmacological and/or local treatment (if any) for venous leg ulcer to local wound care with sterile saline solution or sterile water, "non-active" dressings and standardized compression (same strength and type of compression). They will be administrated the placebo selection treatment for a period of fourteen days.

Three (or four) working days before the inclusion visit, the participants will come to the site for a RU picture in order to get the RU area central measurement for inclusion visit (W000).

At W000, the investigator will check that the inclusion RU area is compliant with the inclusion criteria. The investigator will also check that the participant is compliant with the selection treatment and stockings wearing.

All participants found to be eligible for inclusion will be randomized to one of the following six groups - S42909: 100, 200, 400, 800 or 1200 mg per day- or placebo.

The participants will enter a 6 weeks ambulatory Investigational Medicinal Product (IMP) treatment period on top of standard of care (standardized compression and local wound care with sterile saline solution or sterile water and "non-active" dressing) followed by a 2 weeks follow-up period of standard of care only. During this period the participants will return to the investigator's site for intermediate visits after one week (W001), two weeks (W002), three weeks (W003), four weeks (W004), six weeks (W006) and eight weeks (W008). Participants will continue receiving standardized compression therapy and local wound care (sterile saline solution or sterile water and "non-active" dressing) until the end of the study (W008).

Being tested
S42909 100 mg, S42909 200 mg, S42909 400 mg, S42909 800 mg, S42909 1200 mg
Medical subject headings
Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S42909 100 mgDrug

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

  • S42909 200 mgDrug

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

  • S42909 400 mgDrug

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

  • S42909 800 mgDrug

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

  • S42909 1200 mgDrug

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

  • Placebo Oral TabletDrug

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

Study groups in NCT03077165
Study groupRoleWhat they receive
Group AExperimentalS42909 dose 100 mg p.o., 50 mg bid
Receives: Drug: S42909 100 mg
Group BExperimentalS42909 dose 200 mg p.o., 100 mg bid
Receives: Drug: S42909 200 mg
Group CExperimentalS42909 dose 400 mg p.o., 200 mg bid
Receives: Drug: S42909 400 mg
Group DExperimentalS42909 dose 800 mg p.o., 400 mg bid
Receives: Drug: S42909 800 mg
Group EExperimentalS42909 dose 1200 mg p.o., 600 mg bid
Receives: Drug: S42909 1200 mg
Group FPlacebo comparatorPlacebo p.o. bid
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 4

Secondary outcomes (2)

  1. Adverse Events

    Occurring during the double-blind period of the study

    Measured: Up to 8 weeks

  2. Assessment of Laboratory Parameters

    Biochemistry, Haematology and Fasting Lipids

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2017
  2. Study start12 Sep 2017
  3. Primary completion12 Dec 2019
  4. Study completion22 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03077165
Sponsor's protocol ID
CL2-42909-016
Status last verified
Sep 2020
First submitted
1 Mar 2017
Last updated
8 Oct 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S42909 100 mg, S42909 200 mg and S42909 400 mg in people with Venous Leg Ulcer, run by Ilkos Therapeutic Inc. at 80 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Hungary, Slovakia, Italy, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03077165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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