A trial looking at the safety of RV 001 and how well it works in treating thyroid eye disease. The trial drug or placebo is given intravenously (into a vein) every 3 weeks and allocation to the study drug is by chance.

Phase 1

• Conditions: Thyroid-Associated Ophthalmopathy / Graves' Ophthalmopathy; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-000113-31-IT
• Lead Sponsor: River Vision Development Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-24
• Study Completion: 2017-02-22
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

1.Aged 18-75 years (inclusive).
2.Clinical diagnosis of Graves' disease associated with active TED with a clinical activity score (CAS) = 4 (on the 7 point version of the scale) and moderate to severe TED according to the Clinical Severity Score (CSS) for the most severely affected eye.
3.Fewer than 9 months from onset of TED as determined by patient records.
4.No previous medical or surgical therapy for TED, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent. There must be at least 6 weeks between last administration of steroids and study randomization.
5.Patients must be euthyroid or with mild hypo- or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits. Every effort should be made to correct the mild hypo- or hyperthyroidism promptly.
6.Not requiring immediate surgical ophthalmological intervention.
7.ALT/AST = 3 x the upper limit of normal (ULN) for the reference laboratory; serum creatinine < 1.5 x ULN according to age.
8.Diabetic patients must have a well controlled disease, demonstrated by no change in the diabetes medication (oral or insulin) greater than 10% for the past 60 days
9.Women of child bearing potential, including women with an onset of menopause within the past 2 years (women who have not had at least 12 months of non-therapy-induced amenorrhea or who are not surgically sterile (absence of ovaries and/or uterus), will require a negative pregnancy test at baseline and at all treatment visits up to follow up visit 2 (month 9) post randomization and must be willing and able to use two different methods of contraceptive, one of which must be an oral contraceptive. Male patients must be surgically sterile or must agree to use a barrier contraceptive method. Contraception must be continued for 3 months after the last dose of study drug.
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 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1.Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.
2.Corneal decompensation unresponsive to medical management.
3.Improvement in CAS of = 2 points between screening and baseline.
4.Treatment with oral or intravenous (IV) steroids within the previous 3 months except oral steroids for the treatment of TED with a cumulative dose less than 1000 mg methylprednisolone or equivalent providing there is a 6 week washout prior to study randomization. Administration of any other immunosuppressive agent for any indication in the previous 3 months. Topical steroids for dermatological conditions are not excluded.
5.Any treatment with any investigational agent for any condition in the past 60 days, or treatment with an investigational agent for any condition during the trial.
6. Any previous treatment with Rituximab (Rituxan or MabThera)
7.Previous orbital irradiation.
8.Identified preexisting ophthalmic disease which, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results.
9.Platelet count < 100 x 109/L at screening or baseline. Patients with platelet count < 35 x 109/L following dosing will be withdrawn.
10.Bleeding diathesis.
11.Hemoglobin concentration > 2 gr/dL below the lower limit of the local laboratory reference range.
12.Malignant condition in the past 12 months (with the exception of successfully treated basal cell carcinoma of the skin).
13.Pregnant or lactating women.
14.Drug or alcohol abuse.
15.Poorly controlled diabetes.
16.Known hypersensitivity to any of the components of RV 001 or prior hypersensitivity reactions to monoclonal antibodies.
17.Any other condition which, in the opinion of the investigator, would preclude inclusion in the study.
18.Patients who have already been randomized and received treatment under this protocol. Under no circumstances are patients who enroll in this study permitted to be re-randomized to this study and enrolled for a second course of treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified