Study to Evaluate the Safety and Efficacy of Linsitinib in Patients with Active, Moderate to Severe Thyroid Eye Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sling Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

4 Nov 2022 → 26 Sep 2025

Decision date (initial)

2024-07-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Sling Therapeutics, Inc.

External identifiers

EU CT number

2024-514449-12-00

EudraCT number

2021-005000-36

ClinicalTrials.gov

NCT05276063

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy, Pharmacodynamic, Efficacy, Pharmacokinetic, Safety

The primary objective is to study the effect of linsitinib versus placebo on the proptosis responder rate at Week 24.

Secondary objectives 4

1. Evaluate the effect of linsitinib versus placebo on the mean change from Baseline to Week 24 in proptosis measurement in the primary study eye.
2. Evaluate the effect of linsitinib versus placebo on the overall responder rate Clinical Activity Scale (CAS) and proptosis in the contralateral non-study eye at Week 24
3. Evaluate the effect of linsitinib versus placebo on the percentage of subjects with a CAS value of 0 or 1 at Week 24 in the primary study eye.
4. Evaluate the effect of linsitinib versus placebo on the mean change from Baseline to Week 24 in theGraves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score.

Conditions and MedDRA coding

Disease (TED)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Clinical diagnosis of Graves’ Disease and/or autoimmune Hashimoto’s thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline.
2. TED (not sight-threatening but has an appreciable impact on daily life), with diagnosis of TED within 12 months prior to the Screening visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
3. Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and free triiodothyronine levels [FT3] <50% above or below the normal limits) at Screening.

Exclusion criteria 4

1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
2. Corneal decompensation unresponsive to medical management.
3. Previous orbital irradiation or orbital surgery.
4. Any glucocorticoid use (intravenous [IV] or oral) with a cumulative dose equivalent to ≥ 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proptosis responder rate at Week 24.

Secondary endpoints 4

1. Change from Baseline to Week 24 in proptosis measurement in the primary study eye.
2. Overall responder rate in Clinical Activity Scale (CAS) or proptosis in the contralateral non-study eye at Week 24.
3. Percentage of subjects with a CAS value of 0 or 1 at Week 24 in the primary study eye.
4. Mean change from Baseline to Week 24 in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sling Therapeutics Inc.

Sponsor organisation

Sling Therapeutics Inc.

Address

455 East Eisenhower Parkway Suite 300, Pmb 1048 Pmb 1048

City

Ann Arbor

Postcode

48108-3324

Country

United States

Scientific contact point

Organisation

Sling Therapeutics Inc.

Contact name

Clinical & Medical Operations

Public contact point

Organisation

Sling Therapeutics Inc.

Contact name

Clinical Operations

Third parties 8

Locations

2 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications