Phase
Condition
Rheumatoid Arthritis
Collagen Vascular Diseases
Dermatomyositis (Connective Tissue Disease)
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 to, or inadequate response following at least 3 months of use to, ≥ 3 available treatments, such as the following: corticosteroids, anti-malarialdrugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide,mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab,telitacicept, or B-cell depleting monoclonal antibodies.
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: a. Report from MRI performed within 3 months prior to screening withevidence of muscle inflammation b. Report from muscle biopsy performed within 3months prior to screening that demonstrates active inflammation c. Report fromelectromyography performed within 3 months prior to screening that exhibitsirritable 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.
- Diagnosis of RA:
(a) Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria (b)Positive for ≥ 1 disease-specific autoantibody performed by the central laboratoryat screening: RF or ACPA (c) Moderate or severe disease activity defined as: (i) ≥6tender joints and ≥6 swollen joints AND (ii) DAS28-CRP >3.2. (d) Intolerance to orinadequate response following approximately 3 month's treatment or longer to ≥2b/tsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for takinga treatment in cases of intolerance.
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 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
Sherbrooke, Quebec J1G 2E8
CanadaActive - Recruiting
Research Site
Beijing, 100730
ChinaActive - Recruiting
Research Site
Shanghai, 200001
ChinaActive - Recruiting
Research Site
Wuhan, 430022
ChinaActive - Recruiting
Research Site
Zhengzhou, 450052
ChinaSite Not Available
Research Site
Bordeaux, 33000
FranceActive - Recruiting
Research Site
Montpellier, 34295
FranceActive - Recruiting
Research Site
Nancy, 54035
FranceActive - Recruiting
Research Site
Paris, 75013
FranceActive - Recruiting
Research Site
Paris 2988507, 75013
FranceActive - Recruiting
Research Site
Strasbourg, 67098
FranceActive - Recruiting
Research Site
Toulouse, 31059
FranceActive - Recruiting
Research Site
Cologne, 50937
GermanyActive - Recruiting
Research Site
Erlangen, 91054
GermanyActive - Recruiting
Research Site
Magdeburg, 39120
GermanySite Not Available
Research Site
Pok Fu Lam, 999077
Hong KongSite Not Available
Research Site
Bunkyō City, 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
JapanActive - Recruiting
Research Site
Nagasaki, 852-8501
JapanActive - Recruiting
Research Site
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Research Site
Leiden, 2333
NetherlandsSite Not Available
Research Site
Mérida, 06800
SpainActive - Recruiting
Research Site
Seville, 41010
SpainActive - Recruiting
Research Site
Valladolid, 47012
SpainActive - Recruiting
Research Site
Glasgow, G31 2ER
United KingdomActive - Recruiting
Research Site
London, WC1E 6JF
United KingdomActive - Recruiting
Research Site
London 2643743, SE5 9RS
United KingdomActive - Recruiting
Research Site
Southampton, SO16 6YD
United KingdomActive - Recruiting
Research Site
Anniston, Alabama 36207
United StatesActive - Recruiting
Research Site
Birmingham, Alabama 35233
United StatesSite Not Available
Research Site
La Jolla, California 92037
United StatesSite Not Available
Research Site
Sacramento, California 95817
United StatesSite Not Available
Research Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
Research Site
Omaha, Nebraska 68198
United StatesSite Not Available
Research Site
Chapel Hill, North Carolina 27599
United StatesSite Not Available

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