AzTrials
AzTrials

Diffuse Cutaneous Systemic SclerosisPhase 2NCT04138485

Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)

A Phase 2 study testing IgPro10 in people with Diffuse Cutaneous Systemic Sclerosis, run by CSL Behring at 77 sites in 13 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Cutaneous Systemic Sclerosis
What is being tested?
IgPro10
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
77 sitesin 13 countries
Study dates
20 Dec 2019to 16 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 1. Age ≥18 years (male or female) at time of providing written informed consent
  • Documented diagnosis of SSc according to ACR / EULAR criteria 2013
  • mRSS ≥ 15 and ≤ 45
  • Disease duration ≤ 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
  • Subjects within first 18 months of disease duration from first non-Raynaud's phenomenon manifestation.

Who cannot join

  • Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
  • Positive anti-centromere autoantibodies at Screening
  • Evidence of severe chronic kidney disease with estimated glomerular filtration rate < 45 mL/min/1.73 m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis. Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR < 90 mL/min/1.73m2 will be excluded from the study.
  • History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
  • Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
  • Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index ≥ 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
Show all 10Show fewer
  • Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
  • Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
  • Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
  • Known IgA deficiency or serum IgA level < 5% lower limit of normal

Trial locations and contacts

77 sites in 13 countries.

77 sites in 13 countries

United States20 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48108

  • University of Colorado

    Aurora, Colorado, 80045

  • John Hopkins Bayview Medical Center

    Baltimore, Maryland, 21287

  • Boston University Amyloidosis Center

    Boston, Massachusetts, 02118

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleveland Clinic - Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Altoona Center For Research

    Duncansville, Pennsylvania, 16635

  • Northwell Health

    Great Neck, New York, 11021

  • The University Of Texas Medical School At Houston (Utms)

    Houston, Texas, 77030

  • Pacific Arthritis Care Center

    Los Angeles, California, 90045

  • University of California

    Los Angeles, California, 90095

  • Rutgers Clinical Research Center

    New Brunswick, New Jersey, 08901

  • Hospital For Special Surgery

    New York, New York, 10021

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • University of Pennsylvania - Perelman Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Arizona - Scottsdale

    Scottsdale, Arizona, 85259

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana, 71103

  • Lombardi Cancer Center-Georgetown University

    Washington D.C., District of Columbia, 20007

  • Alliance for Multispecialty Research

    Wichita, Kansas, 67207

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

Other trials in United States

Italy10 sites

  • Universita degli Study di Ancona

    Ancona, 60121

  • Universita Degli Studi Di Bari Aldo Moro

    Bari, 70121

  • Universita degli Studi Di Brescia

    Brescia, 25123

  • Universita degli Studi Firenze

    Florence, 50139

  • UOC Immunoreumatologia

    L’Aquila, 67100

  • Azienda Ospedaliera Gaetano Pini

    Milan, 20122

  • Modena University

    Modena, 41121

  • Universita degli Studi di Napoli Federico II

    Naples, 80138

  • IRCCS Policlinico San Matteo

    Pavia, 27100

  • Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

    Rome, 00161

Other trials in Italy

Germany9 sites

  • Kerckhoff Klinik GmbH, Abteilung für Rheumatologie und Klinische Immunologie Rheumatologie

    Bad Nauheim, 61231

  • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117

  • University Hospital of Cologne

    Cologne, 50937

  • Universitaetsklinikum Freiburg- Klinik fuer Rheumatologie und Klinische Immunologie

    Freiburg im Breisgau, 79106

  • Universitaetsmedizin der Johannes Gutenberg

    Mainz, 55131

  • University Hospital Of Tuebingen

    Tübingen, 72076

  • Universitaetsklinikum Ulm

    Ulm, 89081

  • Hospital St. Josef

    Wuppertal, 42105

Other trials in Germany

France7 sites

  • CHU de Caen

    Caen, 14000

  • CHRU de Lille Hopital Huriez

    Lille, 59037

  • Internal Medicine, Nantes University Hospital

    Nantes, 44000

  • Assistance Publique - Hopitaux de Paris (AP-HP)

    Paris, 75014

  • CHU de Rennes-Hopital Sud

    Rennes, 35203

  • Centre Hospitalier Universitaire de Rouen-Hopital

    Rouen, 76000

  • CHU Hautepierre

    Strasbourg, 67098

Other trials in France

Spain7 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital Universitari Materno Infantil Vall Dhebron

    Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Hospital Univ 12 de Octubre

    Madrid, 28041

  • Hospital Infanta Luisa Quirónsalud

    Seville, 41010

  • Hospital Universitari Dr.Peset

    Valencia, 46017

Other trials in Spain

Mexico6 sites

  • Centro Integral en Reumatologia, SA de CV

    Guadalajara, 44160

  • Centro De Estudios De Investigation Basica Y Clinica S.C

    Jalisco, 44690

  • Instituto Nacional De Ciencias Medicas Y Nutricion

    México, 14080

  • Cliditer, S.A. DE C.V.

    Mexico City, 06700

  • Centro de Investigacion y Tratamiento Reumatologico S.C.

    Mexico City, 11850

  • Centro de Alta Especialidad en Reumatologia

    San Luis Potosí City, 78213

Other trials in Mexico

Poland5 sites

  • Uniwersytecki Szpital Kliniczny W Bialymstoku

    Bialystok, 15-369

  • University Clinical Centre, Medical University of Gdansk

    Gdansk, 80-211

  • Samodzielny Publiczny Szpital Kliniczny

    Katowice, 40-635

  • Klinika Dermatologii Szpital im. Dzieciątka Jezus

    Warsaw, 00-001

  • Klinika i Poliklinika Układowych Chorób Tkanki Łącznej Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, 02-637

Other trials in Poland

Argentina4 sites

  • APRILLUS Asistencia e Investigacion Clinica

    Buenos Aires, C1194AAO

  • Hospital Militar Central

    Buenos Aires, C1426AAL

  • Hospital Italiano de Buenos Aires

    Buenos Aires, S2000SDV

  • Sanatorio Parque S.A y Consultorios Externos Asociados

    Rosario, C1181ACH

Other trials in Argentina

United Kingdom3 sites

  • Countess of Chester Hospital

    Chester, CH2 1UL

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Royal Free Hospital-Royal Free London NHS Foundation Trust

    London, NW3 2QG

Other trials in United Kingdom

Australia2 sites

  • PARC Clinical Research

    Adelaide, South Australia, 5005

  • John Hunter Hospital / Autoimmune Resource and Research Centre

    New Lambton Heights, New South Wales, 2305

Other trials in Australia

Belgium2 sites

  • UZ Gent

    Ghent, 9000

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Canada1 site

  • Mount Sinai Hospital, The Rebecca Macdonald Centre For Arthritis

    Toronto, M5T 3L9

Other trials in Canada

Switzerland1 site

  • Cantonal Hospital St. Gallen - Klinik fuer Rheumatologie

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults With Systemic Sclerosis

This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.

Eligible subjects will be randomized at Baseline in a 2:1 ratio of treatment IgPro10 or placebo in the DB Treatment Period. All subjects who enter OL Treatment Period will receive IgPro10.

Being tested
IgPro10, Placebo
Medical subject headings
Scleroderma, Diffuse

What participants receive

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

  • IgPro10Biological

    Also called Human normal immunoglobulin

    10% liquid formulation of human immunoglobulin for IVIG

  • PlaceboBiological

    Also called Albumin

    0.5% human albumin solution stabilized with 250 mmol/L L-proline

Study groups in NCT04138485
Study groupRoleWhat they receive
IgPro10Experimental10% liquid formulation of human immunoglobulin for intravenous use
Receives: Biological: IgPro10
PlaceboPlacebo comparator0.5% human albumin solution stabilized with 250 mmol/L L-proline
Receives: Biological: Placebo

What is being measured

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

  1. Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo

    Measured: Over 48 weeks

Secondary outcomes (28)

  1. Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events

    Measured: Over 48 weeks

  2. Proportion of responders (ACR CRISS > 0.6)

    Measured: Over 48 weeks

  3. Mean change from Baseline in Modified Rodnan Skin Score (mRSS)

    Measured: Baseline and over48 weeks

  4. Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Measured: Baseline and over 48 weeks

  5. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted

    Measured: Baseline and over 48 weeks

  6. Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted

    Measured: Baseline and over 48 weeks

  7. Mean change from Baseline in Physician Global Assessment (MDGA)

    MDGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)

    Measured: Baseline and over 48 weeks

  8. Mean change from Baseline in Patient Global Assessment (PGA)

    PGA evaluates the overall impact of SSc on the participant as assessed by the physician on a 11-point Numeric rating scale scale from 0 (excellent) to 10 (extremely poor)

    Measured: Baseline and over 48 weeks

  9. Mean change from Baseline in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) total score and subscale

    This survey consists of 34 questions and items are scored on a scale of 0 (better health) to 3 (worse health). Scores are combined to form total score.

    Measured: Baseline and over 48 weeks

  10. Mean change from Baseline in Scleroderma Skin Patient Reported Outcome (SSPRO) score in IgPro10 vs Placebo

    Measured: Baseline and up to 48 weeks

  11. Proportion of responders in mRSS

    Response is decrease of mRSS ≥ 5 points and change of ≥ 25% from Baseline in IgPro10 vs Placebo

    Measured: Up to 48 weeks

  12. Time to treatment failure (time from first infusion to time of first event) in IgPro10 vs Placebo

    Treatment failure - defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all-cause mortality

    Measured: Over 48 weeks

  13. Proportion of subjects with events at Week 48 in IgPro10 vs Placebo

    Events defined as occurrence of SSc associated complications in ACR CRISS step 1 events, digital ischemia (requiring hospitalization for IV prostacyclin, surgical intervention or amputation), serious gastrointestinal events (events requiring parenteral nutrition due to SSc -such as total parenteral nutrition or enteral nutrition), all -cause mortality

    Measured: Over 48 weeks

  14. Mean change from Baseline in Cochin Hand Function Scale in IgPro10 vs Placebo

    Measured: Baseline and over 48 weeks

  15. Mean change from Baseline in Scleroderma Health Assessment Questionnaire (SHAQ) score in IgPro10 vs Placebo

    Measured: Baseline and over 48 weeks

  16. Mean change from baseline in muscle strength as measured by Manual Muscle Testing 8 (MMT) in IgPro10 vs Placebo

    Measured: Baseline and over 48 weeks

  17. Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)

    Measured: Over 48 weeks

  18. Percentage of subjects with AEs, TEAEs, SAEs, AESIs

    Measured: Over 48 weeks

  19. Concentration of serum trough IgG levels at Baseline and prior to first infusion

    Measured: Baseline and up to 72 weeks

  20. Mean change from Baseline in Modified Rodnan skin score (mRSS)

    Measured: Baseline and over 72 weeks

  21. Mean change from Baseline in Patient global assessment (PGA)

    Measured: Baseline and over 72 weeks

  22. Proportion of responders (ACR CRISS > 0.6)

    Measured: Over 72 weeks

  23. Mean change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)

    Measured: Baseline and over 72 weeks

  24. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted

    Measured: Baseline and over 72 weeks

  25. Mean change from Baseline in diffusing capacity of lung for carbon monoxide (DLCO)% predicted

    Measured: Baseline and over 72 weeks

  26. Mean change from Baseline in Physician Global Assessment (MDGA)

    Measured: Baseline and over 72 weeks

  27. Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)

    Measured: Over 72 weeks

  28. Percentage of subjects with AEs, TEAEs, SAEs, AESIs

    Measured: Over 72 weeks

Timeline

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

  1. First posted24 Oct 2019
  2. Study start20 Dec 2019
  3. Primary completion16 Sep 2020
  4. Study completion16 Sep 2020

Why it stopped: Due to business reasons, not safety issues

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04138485
Sponsor's protocol ID
IgPro10_2001
Other IDs
2019-000906-31, 2019
Status last verified
Nov 2020
First submitted
14 Oct 2019
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: CSL will consider requests to share Individual Patient Data (IPD) from systemic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IgPro10 in people with Diffuse Cutaneous Systemic Sclerosis, run by CSL Behring at 77 sites in 13 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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Italy, Germany, France, Spain and 8 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo (time frame: Over 48 weeks). 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 NCT04138485.

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 17 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in