An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Tg Therapeutics Inc.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

21 May 2020 → ongoing

Decision date (initial)

2024-11-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

TG Therapeutics, Inc.

External identifiers

EU CT number

2024-516680-91-00

EudraCT number

2019-003625-16

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To evaluate the long-term safety and efficacy of ublituximab therapy in subjects with relapsing forms of MS

Conditions and MedDRA coding

relapsing multiple sclerosis

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002889-PIP02-20

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study OR complete the final Week 208 visit of the TG1101-RMS201E study.
2. Investigator believes may benefit from treatment with ublituximab
3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
4. Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception

Exclusion criteria 9

1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as: a. Absolute neutrophil count < 1.5 x 10e3/μL b. Hematocrit < 24% c. Platelet count < 150,000 cell/mm3 d. Hypogammaglobulinemia
2. Active infection
3. Ongoing pregnancy (female subjects)
4. Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period OR prior to completing the final Week 208 visit of the TG1101-RMS201E study.
5. Subjects who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301, TG1101-RMS302, OR after the final Week 208 visit of the TG1101- RMS201E study.
6. Subjects who have had a confirmed MS relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, subjects must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE.
7. Subjects with unstable disease activity
8. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
9. Vaccination with live virus within 2 months of randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
2. MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy
3. Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score
4. No Evidence of Disease Activity (NEDA): • NEDA is defined as subjects without relapses, MRI activities (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression. • The percent of subjects with no evidence of disease activity
5. Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)
6. Safety Endpoints: All AEs will be reported and evaluated during the treatment period using NCI CTCAE v.5.0 grading system; the number and severity of infusion-associated events; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Tg Therapeutics Inc.

Sponsor organisation

Tg Therapeutics Inc.

Address

3020 Carrington Mill Boulevard Suite 475

City

Morrisville

Postcode

27560-5435

Country

United States

Scientific contact point

Organisation

Tg Therapeutics Inc.

Contact name

Clinical Support Team

Public contact point

Organisation

Tg Therapeutics Inc.

Contact name

Clinical Support Team

Third parties 10

Locations

2 EU/EEA countries · 11 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 19 files

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

Application history

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