A Phase 2, Proof-of-Concept, Randomized, Double-Masked, Placebo-Controlled Study to Determine the Efficacy and Safety of LASN01 in Patients with Thyroid Eye Disease

Conditions

Thyroid Eye Disease

Brief summary

Efficacy: To assess changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer, Safety: To assess the safety and tolerability of LASN01 compared with placebo in patients with TED as assessed by changes in adverse events, concomitant medications, clinical laboratory evaluations, vital signs, ECGs, and physical examinations

Detailed description

Changes in TED-related clinical parameters (proptosis, CAS, lid retraction, lid aperture, lagophthalmos, Von Graefe’s sign, and diplopia) in the study eye compared to baseline, PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax), PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (Tmax), PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC), PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL), PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz), PK parameter assessed by serum LASN01 concentration at specified timepoints for half-life (t1/2)

Related papers

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Interventions

DRUGLASN01

DRUGSodium Chloride 0.9% Intravenous Infusion BP

DRUGWater for Injections BP.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficacy: To assess changes in proptosis in the study eye compared to baseline as assessed by Exophthalmometer, Safety: To assess the safety and tolerability of LASN01 compared with placebo in patients with TED as assessed by changes in adverse events, concomitant medications, clinical laboratory evaluations, vital signs, ECGs, and physical examinations	—

Secondary

Measure	Time frame
Changes in TED-related clinical parameters (proptosis, CAS, lid retraction, lid aperture, lagophthalmos, Von Graefe’s sign, and diplopia) in the study eye compared to baseline, PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax), PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (Tmax), PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC), PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL), PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz), PK parameter assessed by serum LASN01 concentration at specified timepoints for half-life (t1/2)	—

Measure

Time frame

Changes in TED-related clinical parameters (proptosis, CAS, lid retraction, lid aperture, lagophthalmos, Von Graefe’s sign, and diplopia) in the study eye compared to baseline, PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax), PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (Tmax), PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC), PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL), PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz), PK parameter assessed by serum LASN01 concentration at specified timepoints for half-life (t1/2)

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Countries

Germany, Spain

Outcome results

None listed