STUDY OF ALXN1007 IN ANTIPHOSPHOLIPID SYNDROME SUBJECTS

AN OPEN-LABEL PROOF OF CONCEPT PHASE IIA TRIAL OF ALXN1007 FOR THE TREATMENT OF NON-CRITERIA MANIFESTATIONS OF ANTIPHOSPHOLIPID SYNDROME

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003588-73-GB

Enrollment

Registered

2013-10-21

Start date

2014-07-28

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistently aPL-positive patients with at least 1 of the following non-criteria manifestations: aPL-nephropathy, skin ulcers and/or thrombocytopenia. MedDRA version: 14.1 Level: PT Classification code 10002817 Term: Antiphospholipid syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Code: ALXN1007 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ALXN1007 CAS Number: 1337966-73-0 Other descriptive name: ALXN1007 Concentration unit: mg/ml mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Males or females age 18-75 years. -Patient with persistent and clinically significant aPL profile -Patient must be willing and able to give written informed consent and comply with all study visits and procedures. 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: -Patients meeting the ACR classification criteria for systemic lupus erythematosus, systemic sclerosis or other systemic autoimmune diseases other than Primary APS. -Patients experiencing an acute thrombosis or a Major Adverse Vascular Event (MAVE) within 12 weeks prior to first administration of study drug. -History of an uncontrolled thyroid disorder or abnormal Thyroid Stimulating Hormone (TSH) or free thyroxine (FT4), at screening. -Unresolved meningococcal disease. -Known hypersensitivity to human immunoglobulin proteins or excipients of ALXN1007. -Women who are pregnant or nursing.

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety and Tolerability of ALXN1007;Secondary Objective: -Evaluate Pharmacokinetic parameters -Evaluate Pharmacodynamic effects -Assess Efficacy of ALXN1007;Primary end point(s): Safety;Timepoint(s) of evaluation of this end point: 36 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): Pharmacokinetic, pharmacodynamic and efficacy parameters;Timepoint(s) of evaluation of this end point: 24 weeks	—

Countries

Spain, United Kingdom, United States

Contacts

Public ContactEuropean Clinical Trial Information

Alexion Europe SAS

clinicaltrials.eu@alxn.com+33153643848

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026