Safety and Efficacy of Abatacept in IgG4-Related Disease

NCT03669861 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IM101-744
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, single center, proof of concept clinical trial in subjects with active IgG4-Related Disease (IgG4-RD). Approximately 10 subjects with active IgG4-RD will be enrolled into this study. Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks).

Conditions

IgG4-related Disease

Outcome Measures

Primary Outcomes (1)

• Treatment Response

  Effect of weekly subcutaneous (SC) administration of abatacept on complete remission

  24 weeks

Secondary Outcomes (5)

• Disease Response

  12 weeks

• Disease Response at Week 24

  disease response at 24 weeks

• Disease Remission: Flares Over Time Per Subject

  24 weeks

• Decline in Serum IgG4 Concentration of Responders

  24 Weeks

• Decline in Serum IgE Concentration of Responders

  24 weeks

Study Arms (1)

Abatacept

EXPERIMENTAL

To assess the effect of weekly subcutaneous (SC) administration of abatacept on complete remission of IgG4-RD

Drug: Abatacept

Interventions

Abatacept DRUG

Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks)

Also known as: Orencia

Abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are male or female 18 years of age or older
• Meet the American College of Rheumatology (ACR)/EULAR 2018 Classification Criteria for IgG4-RD
• Have active disease based on an IgG4-RD Responder Index (RI) ≥2 at screening with disease manifestation in at least one organ system excluding lymph nodes at screening
• May or may not have received prior IgG4-RD therapy
• Must be willing to taper off any systemic corticosteroid therapy within 4 weeks of first dose of trial drug.
• Must be able and willing to discontinue any immunosuppressive agent at screening (e.g. methotrexate, mycophenolate mofetil, 6-mercaptopurine, tacrolimus, cyclophosphamide or azathioprine).
• No history of severe allergic reactions to monoclonal antibodies.
• Are able and willing to complete the entire study according to the study schedule.
• Are willing to forego other forms of experimental treatment during the study.
• Are able to provide written informed consent.

You may not qualify if:

• History or evidence of a clinically unstable/uncontrolled disorder, condition or disease (including but not limited to cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic or psychiatric) other than IgG4-RD that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures or completion.
• Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no recurrence ≥3 years following prostatectomy).
• Liver disease: Acute or chronic non-IgG4-related liver disease deemed sufficiently severe to impair their ability to participate in the trial.
• Uncontrolled disease: evidence of another uncontrolled condition, including drug and alcohol abuse, which could interfere with participation in the trial according to the protocol.
• Presence of recurrent or chronic infections, defined as ≥3 infections requiring antimicrobials over the past 6 months prior to screening.
• Active infection requiring hospitalization or treatment with parenteral antimicrobials within the 30 days prior to randomization.
• Prior use of rituximab (or other B cell depleting agents) within 6 months of enrollment unless B cells have been demonstrated to have repopulated.
• Use of any investigational agent within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment.
• White blood cell count \< 2.5 x 103/µL.
• Absolute neutrophil count (ANC) \< 1.0 x 103/µL.
• IgG4-related renal disease with serum creatinine \>2.0 mg/dL.
• Hemoglobin \< 10 g/dL.
• Platelet count \< 75 x 109/L.
• Known positive result for HIV I or II antibody, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody.
• Has received live vaccines within 4 weeks of enrollment.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Limitations and Caveats

The trial also comes with additional limitations, specifically the small number of patients, the lack of a comparator group, and the open-label design.

Results Point of Contact

• Title: DRAI Director of Clinical Trials
• Organization: Massachusetts General Hospital

JHSTONE@mgh.harvard.edu

6176920668

Study Officials

• John H Stone, MD

  Massachusetts General Hospital and Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Rheumatology

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: September 13, 2018
• Study Start: November 13, 2018
• Primary Completion: April 10, 2020
• Study Completion: November 10, 2020
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-07

Locations

US (1)