SCIg Therapy for COPD
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen bySyed S Mustafa, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Rochester General Hospital
Must be taking: Triple therapy
Must not be taking: Immunoglobulin, Estrogens
Disqualifiers: Humoral dysfunction, Obesity, Diabetes, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses a treatment to help COPD patients with immune system problems by boosting the body's antibodies to fight infections. The therapy has been shown to be effective and safe, with benefits such as improved efficacy, tolerability, and patient satisfaction.
Will I have to stop taking my current medications?
The trial requires participants to have been on triple therapy (a combination of inhaled corticosteroid, long-acting beta2-adrenergic agonist, and long-acting muscarinic antagonist) for more than 90 days before joining. It does not specify if you need to stop other medications, so it's best to discuss with the trial team.
Is SCIg Therapy generally safe for humans?
SCIg Therapy, including CUVITRU, has been shown to be generally safe in humans, with most side effects being mild or moderate. Studies in patients with primary immunodeficiency diseases reported no serious treatment-related adverse events.
12345How is the drug CUVITRU different from other treatments for COPD?
CUVITRU is unique because it is administered subcutaneously (under the skin) rather than intravenously (into a vein), which can be more convenient for patients as it allows for home-based treatment. While traditionally used for immune deficiencies, its use in COPD is novel and may offer a new approach for managing this condition.
15678Eligibility Criteria
Adults aged 18-82 with COPD who've had at least two severe flare-ups in the past year or one requiring hospitalization, despite being on triple therapy for over 90 days. They must be medically stable, not currently smoking, and without certain other health issues like severe liver or kidney disease, blood clotting disorders, or a history of organ transplant.Inclusion Criteria
I am between 19 and 82 years old.
Meet three (3) or more of the following criteria: Dyspnea ≥ 5 on a visual analog scale, Respiratory rate ≥ 24 breaths per minute, Heart rate ≥ 95 beats per minute, Resting SaO2 < 92% breathing ambient air or change in saturation > 3% from baseline, CRP ≥ 10 mg/L, Established diagnosis of COPD with specific PFT criteria, Adherence with triple therapy for > 90 days, ≥ 2 steroid-requiring exacerbations or one hospitalization in the past 12 months, Medically stable with no recent acute hospitalizations, Expected life expectancy > 1 year, Stable Cardiovascular Disease, No history of pulmonary embolism, Hepatic function < Class B Child-Pugh criteria, Renal insufficiency with eGFR > 60 mL/min/1.73m2, No history of DVT or thrombotic events, No history of organ transplant, Negative pregnancy test for females of childbearing potential, Adherence to contraception for males, Ability to sign informed consent
Exclusion Criteria
Known history of humoral dysfunction/immunodeficiency, Known hereditary/genetic/congenital defects, autoimmune disease, ongoing or recent therapy with immunoglobulin replacement therapy, Chronic oral steroid use of prednisone ≥20 mg daily, Alpha-1 antitrypsin deficiency, Obesity with BMI > 40, Unstable hypertension, Diabetes mellitus Type I, Known history of thrombophilia disorders, Risk factors of hemolysis, prolonged immobilization, severe hypovolemia, hypercoagulable conditions, use of estrogens, Indwelling central vascular catheters, Currently actively smoking
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Evaluation
Patients are evaluated by checking serum IgG, IgM, and IgA, as well as baseline and post-vaccine IgG to peptide and polysaccharide antigens
2 weeks
Treatment
Patients with humoral dysfunction are randomized to receive either SCIgR with Cuvitru 125 mg/kg/week plus standard of care or standard of care alone
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on AECOPD events and rehospitalization rates
4 weeks
Participant Groups
The trial is testing if Subcutaneous Immune Globulin Replacement Therapy (SCIgR) can reduce exacerbations in COPD patients with humoral immunodeficiency. It involves comparing SCIgR plus standard medical therapy against standard treatment alone to see which is more effective.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group #1Experimental Treatment2 Interventions
SCIgR with Cuvitru 125 mg/kg/week + standard of care management
Group II: Group #2Placebo Group1 Intervention
Standard of care management = 20 patients
CUVITRU - Ig subcutaneous human 20% is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as CUVITRU for:
- Primary immunodeficiency diseases
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
🇪🇺 Approved in European Union as CUVITRU for:
- Primary immunodeficiency diseases
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
🇨🇦 Approved in Canada as CUVITRU for:
- Primary immunodeficiency diseases
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rochester Regional Health - Ctr for Clinical Research - GreeceRochester, NY
Rochester Regional Health Ctr for Clinical Research - Alexander ParkRochester, NY
Rochester Regional Health - Ctr for Clinical Research - Linden OaksRochester, NY
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Who Is Running the Clinical Trial?
Rochester General HospitalLead Sponsor
TakedaIndustry Sponsor
References
Infusion parameters of 20% subcutaneous immunoglobulin for primary immunodeficiency diseases among patient support program participants. [2021]The safety and efficacy of subcutaneous immune globulin 20% (human) solution (Cuvitru; Ig20Gly) for primary immunodeficiency disease (PID) have been demonstrated in 2 pivotal trials.
Cutaquig® Is Well Tolerated in Immunodeficient Patients Who Did Not Tolerate Other Subcutaneous Immunoglobulin Products. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Subcutaneous immunoglobulin (SCIG) treatment is generally tolerable, but some patients may experience adverse events to one or more SCIG products. We investigated whether 16.5% Cutaquig® treatment offered a tolerable and safe alternative treatment for immunodeficient patients.
Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. [2022]Subcutaneous human IgG (SCIG) therapy in primary immunodeficiency (PID) offers sustained IgG levels throughout the dosing cycle and fewer adverse events (AEs) compared to intravenous immunoglobulin (IVIG). A phase I study showed good local tolerability of IgPro20, a new 20% liquid SCIG stabilized with L-proline. A prospective, open-label, multicenter, single-arm, phase III study evaluated the efficacy and safety of IgPro20 in patients with PID over 15 months. Forty-nine patients (5-72 years) previously treated with IVIG received weekly subcutaneous infusions of IgPro20. The mean serum IgG level was 12.5 g/L. No serious bacterial infections were reported. There were 96 nonserious infections (rate 2.76/patient per year). The rate of days missed from work/school was 2.06/patient per year, and the rate of hospitalization was 0.2/patient per year. Ninety-nine percent of AEs were mild or moderate. No serious, IgPro20-related AEs were reported. IgPro20 effectively protected patients with PID against infections and maintained serum IgG levels without causing unexpected AEs.
Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens. [2023]To achieve reductions in infusion time, infusion sites, and frequency, a prospective, open-label, multicenter, Phase 3 study evaluated the safety, efficacy, and tolerability of subcutaneous immunoglobulin (SCIG) 16.5% (Cutaquig®, Octapharma) at enhanced infusion regimens.
Long-Term Experience of Subcutaneous Immunoglobulin Therapy in Pediatric Primary Immunodeficient Patients with Low and Normal Body Weight. [2022]The aim was to review the compliance, side effects and effectiveness of subcutaneous immunoglobulin (SCIG) supplementation in patients with primary immunodeficiencies (PID) who had previously received intravenous immunoglobulin (IVIG) therapy and subsequently switched to SCIG, as well as to compare these parameters in patients while considering body weight.
Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency. [2022]Subcutaneous immunoglobulin (SCIG) therapy is an alternative to intravenous immunoglobulin (IVIG) therapy.
[Subcutaneous gammaglobulin in common variable immunodeficiency. First experience in Spain]. [2022]Weekly home-based subcutaneous immunoglobulin (SCIg) therapy is an alternative to intravenous immunoglobulin (IVIg) in the treatment of patients with primary antibody deficiencies. The objective of this study was to investigate the efficacy, safety, related quality of life and cost effectiveness of SCIg in our area.
Subcutaneous immunoglobulin therapy in an 11-year-old patient with common variable immunodeficiency and von Willebrand disease. [2009]Subcutaneous immunoglobulin (SCIG) is an option for replacement therapy in patients with humoral immune deficiencies.