Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus

• Register: EUCTR
• Last refreshed on: 26 February 2018
• Main ID: EUCTR2015-000372-95-CZ
• Date of registration: 16/06/2015
• Prospective Registration: Yes
• Primary sponsor: Ablynx N.V.
• Public title: Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus
• Scientific title: A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY
• Date of first enrolment: 20/08/2015
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000372-95
• 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: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Chile, Czech Republic, Germany, Hungary, Korea, Republic of, Mexico, Peru, Philippines, Poland, Portugal, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United States

Contacts

• Affiliation: Ablynx N.V.

• Affiliation: Ablynx N.V.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female adults = 18 years and < 65 years of age.
2. Have a diagnosis of SLE for at least 6 months prior to screening and
fulfill the 1997 ACR or 2012 Systemic Lupus International Collaborating
Clinics (SLICC) classification criteria.
3. Have moderate to severe active SLE.
5. Have seropositive disease at screening.
6. Subject must be at least on one or more of the treatments for SLE as
defined in the protocol.
Others as defined in the protocol.
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 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Have an A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal system at screening and at
baseline for the organ systems that can be clinically assessed.
2. Have a systemic inflammatory disease other than SLE.
3. Clinically significant infection treated or needing treatment.
4. Any active or recurrent viral infection that based on the
Investigator´s clinical assessment makes the subject unsuitable for the
study.
5. Have a history of, or current, class III or IV congestive heart failure.
6. Have received prior therapy blocking the IL-6 pathway.
Others as defined in the protocol.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic System Organ Class: 100000017968

Intervention(s)

Product Name: ALX-0061 150 mg/mL
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: vobarilizumab
CAS Number: 1628814-88-9
Current Sponsor code: ALX-0061
Other descriptive name: IL-6R nanobody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The percentage of subjects who achieved a response at Week 24 according to the composite mBICLA (BILAG-based Combined Lupus Assessment) score.

Timepoint(s) of evaluation of this end point: Week 24

Main Objective: To assess the efficacy and safety of different dose regimens of ALX-0061 administered subcutaneously (s.c.) to subjects with moderate to severe active, seropositive SLE compared to placebo.

Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, flare rate, steroid reduction and health-related quality of life, with different dose regimens of ALX-0061.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) From screening to Week 48
2) Week 48
3) Week 48
4) Week 24 and Week 48
5) Week 24 and Week 48
6) Week 24 and Week 48
7) Week 24 and Week 48
8) Week 48
9) Week 12, Week 24 and Week 48
10) Week 48
11) Week 60
12) Week 60
13) Week 60
14) From screening to week 60

Secondary end point(s): 1) Change in SLE disease activity as measured by change in: composite
(m)BICLA, mSRI (modified Systemic lupus erythematosus responder
index), standard SRI, (m)SRI with more stringent (m)SLEDAI-cut-offs:
SRI-5, SRI-6, SRI-7, SRI-8, mSLEDAI-2K, standard SLEDAI 2K, BILAG-
2004, physician's global assessment
2) The change from baseline in patient's global assessment over time.
3) The change from baseline in renal parameters
4) The number of patients with treatment failures
5) The number of patients with a reduction in flare rate
6) The change from baseline in corticosteroids use
7) The change from baseline in the physical and mental component
scores of SF-36
8) Change from baseline in joints count over time
9) The change from baseline of Cutaneous lupus erythematosus
disease area and severity index (CLASI)
10) The determination of ALX-0061 in blood samples
11) The determination of biomarkers in blood samples
12) The determination of anti-ALX-0061 antibodies in blood samples
13) The incidence of adverse events and serious adverse events.
14) The change from baseline in clinical laboratory parameters.

Secondary ID(s)

ALX0061-C204

NCT02437890

Source(s) of Monetary Support

Ablynx N.V.