Phase
Condition
Systemic Lupus Erythematosus
Dystonias
Collagen Vascular Diseases
Treatment
AZD5492
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 18 to 70 years of age inclusive, at the time of signing theinformed consent.
Diagnosis of SLE:
Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria forSLE
Positive for one or more of: anti-nuclear antibodies (titre ≥ 1:80), anti-dsDNAor anti-Sm at screening.
Active, moderate-severe disease at screening, defined as clinical SLEDAI-2K ≥
Intolerance or inadequate response to ≥ 3 available SOC treatments, used for atleast 3 months each, for which at least one must be a biologic SoC orcyclophosphamide.
Diagnosis of IIM:
Must have "probable" or "definite" diagnosis of PM or DM (excluding IBM andcancer associated myositis) according to the 2017 EULAR/ACR classificationcriteria for adult myositis.
Positive for ≥ 1 disease-specific autoantibody at screening.
MMT-8 score of ≤ 142/150 and/or CDASI-A > 6
Fulfill at least one of the following criteria of active disease at screening:
(i) One or more muscle enzyme elevation (CK, AST, ALT, aldolase, LDH) ≥ 1.3 × ULN (ii) If criterion 3(d)(i) is not met, then at least one of the following criteriamust be met:
Report from MRI performed within 3 months prior to screening with evidence ofmuscle inflammation
Report from muscle biopsy performed within 3 months prior to screening thatdemonstrates active inflammation
Report from electromyography performed within 3 months prior to screening thatexhibits irritable myopathic pattern.
(e) Intolerance or inadequate response to corticosteroids and ≥2 other SoCtreatments, used for at least 3 months each, for which at least one must be abiologic SoC, immunoglobulin or cyclophosphamide.
For participants receiving any of the following therapies at screening:
Oral prednisone (or equivalent): Daily dose ≤ 20 mg/day and must be stable for ≥ 1 week prior to Day 1.
Immunosuppressive treatment: for ≥ 3 months prior to Day 1 and at a stable dosefor ≥ 4 weeks prior to Day 1.
Exclusion
Exclusion Criteria:
Any complications of the disease under study which are judged by the investigator tobe life or organ threatening or to require treatments which are not permitted in theprotocol, including but not limited to:
Active severe SLE-driven renal disease.
History of, or current diagnosis of, catastrophic or severe APS (for examplediagnosis of an arterial or central/pulmonary venous clot) within 1 year priorto signing the ICF.
Rapidly progressive and/or severe ILD or ILD that requires oxygensupplementation/therapy (of any type).
Inclusion Body Myositis or cancer associated myositis.
Active severe, unstable or history of neuropsychiatric SLE
IIM: Pulmonary function tests at screening (or within one month of screening,provided participant confirms no change in respiratory symptoms in the interim)which meet any of the following criteria:
FVC ≤60% of predicted
DLCO ≤70% of predicted
Deterioration in either FVC or DLCO at screening compared to pulmonary functiontests performed ≥3 months previously.
Significant history of or at risk of severe infections.
Participants with HIV infection
Participants with active EBV or CMV.
Participants with evidence of chronic or active hepatitis B defined as HBsAgpositive or HBcAB positive
Participants with evidence of chronic or active hepatitis C
Participants with positive COVID-19 PCR.
Known history of a primary immunodeficiency, splenectomy, or any underlyingcondition that predisposes the participant to infection.
Significant CNS pathology.
Receipt of B-cell-depleting therapy including CD19 or CD20 directed monoclonalantibodies (including but not limited to, ocrelizumab, ofatumumab, obinutuzumab, orrituximab) <3 months prior to Day 1.
Study Design
Study Description
Connect with a study center
Research Site
Hamilton, Ontario L8S 4K1
CanadaSite Not Available
Research Site
Hamilton 5969782, Ontario 6093943 L8S 4K1
CanadaSite Not Available
Research Site
Sherbrooke, Quebec J1G 2E8
CanadaSite Not Available
Research Site
Sherbrooke 6146143, Quebec 6115047 J1G 2E8
CanadaSite Not Available
Research Site
Beijing, 100730
ChinaSite Not Available
Research Site
Beijing 1816670, 100730
ChinaSite Not Available
Research Site
Shanghai, 200001
ChinaSite Not Available
Research Site
Shanghai 1796236, 200001
ChinaActive - Recruiting
Research Site
Wuhan, 430022
ChinaSite Not Available
Research Site
Wuhan 1791247, 430022
ChinaActive - Recruiting
Research Site
Bordeaux, 33000
FranceSite Not Available
Research Site
Bordeaux 3031582, 33000
FranceActive - Recruiting
Research Site
Montpellier, 34295
FranceSite Not Available
Research Site
Montpellier 2992166, 34295
FranceActive - Recruiting
Research Site
Nancy, 54035
FranceSite Not Available
Research Site
Nancy 2990999, 54035
FranceActive - Recruiting
Research Site
Paris, 75013
FranceSite Not Available
Research Site
Paris 2988507, 75013
FranceActive - Recruiting
Research Site
Strasbourg 2973783, 67098
FranceSite Not Available
Research Site
Strasbourg Cedex, 67098
FranceSite Not Available
Research Site
Toulouse, 31059
FranceSite Not Available
Research Site
Toulouse 2972315, 31059
FranceActive - Recruiting
Research Site
Cologne 2886242, 50937
GermanySite Not Available
Research Site
Erlangen, 91054
GermanySite Not Available
Research Site
Erlangen 2929567, 91054
GermanySite Not Available
Research Site
Köln, 50937
GermanySite Not Available
Research Site
Magdeburg, 39120
GermanySite Not Available
Research Site
Magdeburg 2874545, 39120
GermanySite Not Available
Research Site
Bunkyo-ku, 113-8655
JapanSite Not Available
Research Site
Bunkyō City 11790632, 113-8655
JapanActive - Recruiting
Research Site
Kita-gun, 761-0793
JapanActive - Recruiting
Research Site
Kitakyushu-shi, 807-8555
JapanActive - Recruiting
Research Site
Kyoto, 606-8501
JapanSite Not Available
Research Site
Kyoto 1857910, 606-8501
JapanActive - Recruiting
Research Site
Nagasaki 1856177, 852-8501
JapanActive - Recruiting
Research Site
Nagasaki-shi, 852-8501
JapanSite Not Available
Research Site
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Research Site
Amsterdam 2759794, 1105 AZ
NetherlandsSite Not Available
Research Site
Leiden, 2333
NetherlandsSite Not Available
Research Site
Leiden 2751773, 2333
NetherlandsSite Not Available
Research Site
Mérida, 06800
SpainSite Not Available
Research Site
Mérida 2513917, 06800
SpainActive - Recruiting
Research Site
Sevilla, 41010
SpainSite Not Available
Research Site
Seville 2510911, 41010
SpainActive - Recruiting
Research Site
Valladolid, 47012
SpainSite Not Available
Research Site
Valladolid 3106672, 47012
SpainActive - Recruiting
Research Site
Glasgow, G31 2ER
United KingdomSite Not Available
Research Site
Glasgow 2648579, G31 2ER
United KingdomActive - Recruiting
Research Site
London, WC1E 6JF
United KingdomSite Not Available
Research Site
London 2643743, WC1E 6JF
United KingdomActive - Recruiting
Research Site
Southampton, SO16 6YD
United KingdomSite Not Available
Research Site
Southampton 2637487, SO16 6YD
United KingdomActive - Recruiting
Research Site
Anniston, Alabama 36207
United StatesSite Not Available
Research Site
Anniston 4830198, Alabama 4829764 36207
United StatesActive - Recruiting
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