A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Specified dose on specified days
Omega Research
Orlando, Florida, United States
RECRUITINGNew York University
Brooklyn, New York, United States
RECRUITINGSafety and Tolerability
Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).
Time frame: 48 weeks
To evaluate the PK of CLN-978
Serum concentrations of CLN-978
Time frame: 48 weeks
Detection of anti-drug antibodies
Detection of anti-drug antibodies
Time frame: 48 weeks
Change from baseline in B lymphocyte cell numbers in peripheral blood
B lymphocyte cell numbers and change from baseline in peripheral blood
Time frame: 48 weeks
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Regional One
Memphis, Tennessee, United States
RECRUITINGStryde Research
Plano, Texas, United States
RECRUITINGTranquil Research
Webster, Texas, United States
RECRUITINGIntermountain
Salt Lake City, Utah, United States
RECRUITINGCHU Brest
Brest, France
RECRUITINGHopitaux Universitaires Paris-Sud
Le Kremlin-Bicêtre, France
RECRUITINGCHU Nantes
Nantes, France
RECRUITINGCHU St.-Étienne
Saint-Priest-en-Jarez, France
RECRUITING...and 4 more locations