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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 August 2020
Main ID:  EUCTR2019-003430-16-FR
Date of registration: 02/06/2020
Prospective Registration: Yes
Primary sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Public title: Safety and efficacy of itacitinib in adults with systemic sclerosis
Scientific title: Safety and efficacy of itacitinib in adults with systemic sclerosis: a phase II, randomized, controlled trial - SCLERITA - SCLERITA
Date of first enrolment: 28/07/2020
Target sample size: 74
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003430-16
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
France
Contacts
Name: DRCI Hôpital St Louis   
Address:  1 av. Claude Vellefaux 75010 PARIS France
Telephone: 33144841738
Email: josephine.braun@aphp.fr
Affiliation:  ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Name: DRCI Hôpital St Louis   
Address:  1 av. Claude Vellefaux 75010 PARIS France
Telephone: 33144841738
Email: josephine.braun@aphp.fr
Affiliation:  ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Key inclusion & exclusion criteria
Inclusion criteria:
- Adult patient (>/= 18 years old),
- Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,
- Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,
- Patient with a modified Rodnan skin score (mRSS) > /= 10 and < /= 35 units at screening,
- Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months duration of the study,
- Patient able to give written informed consent prior to participation in the study,
- Affiliation to a social security scheme (profit or being entitled)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion criteria:
- Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
- Contra-indications to itacitinib or Janus kinase inhibitor,
- Failure to sign the informed consent or unable to consent
- Patient participating in another investigational therapeutic study,
- Current, or history of recurrent infections, including HBV, HCV, HIV
- Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
- Patient suspected not to be observant to the proposed treatments,
- Patient who have white blood cell count = 4,000/mm3,
- Patient who have platelet count = 100,000/mm3,
- Patients who have ALT or AST level greater that 3 times the upper limit of normal
- Patient who have triglyceride level greater than 5g/L
- Pregnant or breastfeeding woman.
- Patient receiving or having received mycophenolate mofetil or methotrexate within the last month (possible inclusion beyond one month),
- Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),
- Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening
MedDRA version: 21.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Product Name: Itacitinib
Product Code: INCB039110
Pharmaceutical Form: Tablet
INN or Proposed INN: ITACITINIB
Current Sponsor code: INCB039110
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The main objective of this study is to show a decrease of skin fibrosis, as evaluated by the modified Rodnan skin score, after 360 days of treatment, in patients with diffuse SSc treated with itacitinib when compared to patients treated with a placebo
Primary end point(s): The primary outcome is the change in modified Rodnan skin score at 360 days.
Secondary Objective: - to evaluate the safety of itacitinib in patients with SSc
- to compare the efficacy of itacitinib versus placebo in terms of disease activity, quality of life and disability
Timepoint(s) of evaluation of this end point: Day 360
Secondary Outcome(s)
Secondary end point(s): Security profile:
- Proportion of patients deceased at 360 days
- Adverse events at 180 and 360 days
- Severe adverse events at 180 and 360 days.

SSc disease activity
- Change in modified Rodnan skin score at 90, 180, 270 days
- Proportion of patients with an improved modified Rodnan skin score at 90, 180, 270, 360 days
- Proportion of patients with an active disease according to the EUSTAR SSc activity score at 180 and 360 days.
- Change in the Combined Response Index in Diffuse Systemic Sclerosis (CRISS) score
- Physicians and patients visual analogue scales

Quality of life and disability
- SF-36 and EQ5D scales
- HAQ-DI scale
Timepoint(s) of evaluation of this end point: at 90, 180, 270, 360 days
Secondary ID(s)
APHP180613
Source(s) of Monetary Support
Ministry of Health
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/07/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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