SCIg Therapy for COPD

Recruiting at 2 trial locations

Overseen By Holly Blue, LPN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rochester General Hospital

Must be taking: Triple therapy

Must not be taking: Immunoglobulin, Estrogens

Disqualifiers: Humoral dysfunction, Obesity, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with Chronic Obstructive Pulmonary Disease (COPD) to determine if it can reduce flare-ups by boosting the immune system. Participants will receive either an immune-boosting therapy called SCIgR (a type of immune support treatment, also known as CUVITRU - Ig subcutaneous human 20%) or a placebo, along with their usual care. This trial targets individuals experiencing COPD symptoms, such as frequent breathing issues, and who have had at least two recent flare-ups requiring steroid treatment. Those managing COPD with inhalers and still facing these challenges might find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

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 there any evidence suggesting that CUVITRU - Ig subcutaneous human 20% is likely to be safe for humans?

Research has shown that CUVITRU, a 20% subcutaneous immune globulin, is generally safe and well-tolerated. In a study with 77 participants, researchers found no major safety issues. Most side effects were mild, such as redness at the injection site. Its use in other conditions further supports its safety. Studies indicate that long-term use of CUVITRU has not led to significant safety problems, providing confidence in its safety for users. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Researchers are excited about CUVITRU for COPD because it represents a novel approach to managing this condition. Unlike current treatments, which often include bronchodilators and steroids to manage symptoms, CUVITRU uses a subcutaneous immunoglobulin (SCIg) therapy that could potentially modify the disease mechanism itself. This treatment is designed to be administered under the skin, offering a more convenient and less invasive option compared to intravenous methods. Additionally, CUVITRU targets the immune system in a way that could reduce inflammation and enhance lung function, providing a new hope for individuals with COPD.

What evidence suggests that CUVITRU might be an effective treatment for COPD?

Research has shown that people with COPD often have lower levels of immunoglobulin G (IgG), an antibody that helps fight infections. In this trial, one group of participants will receive CUVITRU, a treatment administered under the skin to boost these antibodies, alongside standard care. Patients in previous studies who used this treatment experienced fewer flare-ups of COPD symptoms, known as acute exacerbations of COPD (AECOPD). While more research is needed to confirm its effectiveness, the treatment appears promising for reducing these flare-ups in patients with compromised immune systems. Overall, early findings suggest CUVITRU could help manage COPD by reducing the frequency of these episodes. ^{2 3 4 6 7}

Who Is on the Research Team?

Syed S Mustafa, MD

Principal Investigator

Rochester General Hospital

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CUVITRU - Ig subcutaneous human 20%

Trial Overview 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.

How Is the Trial Designed?

Group I: Group #1 Experimental Treatment 2 Interventions

SCIgR with Cuvitru 125 mg/kg/week + standard of care management

Group II: Group #2 Placebo Group 1 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)

Who Is Running the Clinical Trial?

Rochester General Hospital

Lead Sponsor

Trials

14

Recruited

2,300+

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Published Research Related to This Trial

In a study of 82 patients with antibody deficiencies, subcutaneous immunoglobulin (SCIG) therapy with Vivaglobin was found to be more effective than previous intravenous immunoglobulin (IVIG) treatment, with a higher mean serum IgG trough level (7.5 g/L vs. 6.6 g/L).

The majority of patients (89%) rated the efficacy of SCIG as 'excellent', and significant improvements in health-related quality of life were observed, with 92% of patients preferring SCIG over IVIG and 83% favoring home therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency. Hoffmann, F., Grimbacher, B., Thiel, J., et al.[2022]

In a real-world study of 817 patients with primary immunodeficiency disease (PID) using subcutaneous immune globulin 20% (Ig20Gly), most patients completed their infusions in under 1 hour and typically used fewer than 2 infusion sites, aligning with previous clinical trial results.

The study found that infusion parameters, such as the rate and volume, were consistent across different age groups and previous treatment experiences, indicating that Ig20Gly can be effectively administered in a variety of patient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infusion parameters of 20% subcutaneous immunoglobulin for primary immunodeficiency diseases among patient support program participants. Meckley, LM., Wu, Y., Tzivelekis, S., et al.[2021]

A phase III study involving 49 patients with primary immunodeficiency demonstrated that subcutaneous IgPro20 therapy effectively maintained serum IgG levels and provided protection against infections over 15 months, with a mean serum IgG level of 12.5 g/L.

The therapy was well-tolerated, with 99% of adverse events being mild or moderate, and no serious IgPro20-related adverse events or serious bacterial infections reported, indicating a favorable safety profile compared to traditional intravenous immunoglobulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. Hagan, JB., Fasano, MB., Spector, S., et al.[2022]

Subcutaneous immunoglobulin (SCIg) therapy resulted in higher median trough serum IgG levels (850 mg/dl) compared to intravenous immunoglobulin (IVIg) (622 mg/dl), indicating better immunoglobulin maintenance in patients with common variable immunodeficiency (CVID).

Switching to home-based SCIg therapy not only improved patients' quality of life but also proved to be cost-effective, with a similar annual infection rate compared to IVIg and manageable mild adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Subcutaneous gammaglobulin in common variable immunodeficiency. First experience in Spain]. Maroto Hernando, M., Soler Palacín, P., Martin Nalda, N., et al.[2022]

A Phase 3 study involving 64 participants demonstrated that subcutaneous immunoglobulin (SCIG) 16.5% (Cutaquig®) can be administered at higher volumes and flow rates than previously labeled limits, with Cohort 1 achieving up to 108 mL/site and Cohort 2 achieving a flow rate of 67.5 mL/hr/site.

The new infusion regimens were well tolerated, with no serious bacterial infections reported, and showed equivalent efficacy to weekly dosing when administered every other week, indicating a safer and more convenient treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Immunoglobulin 16.5% (Cutaquig®) in Primary Immunodeficiency Disease: Safety, Tolerability, Efficacy, and Patient Experience with Enhanced Infusion Regimens. Gupta, S., DeAngelo, J., Melamed, I., et al.[2023]

Subcutaneous immunoglobulin (SCIG) therapy is effective for pediatric patients with primary immunodeficiencies (PID), leading to higher and more stable serum IgG levels compared to intravenous immunoglobulin (IVIG) therapy.

Patients experienced significantly fewer hospitalizations and infections after switching to SCIG, and the treatment was found to be safe for children with low body weight, with minimal side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Experience of Subcutaneous Immunoglobulin Therapy in Pediatric Primary Immunodeficient Patients with Low and Normal Body Weight. Gul, Y., Kapakli, H., Guner, SN., et al.[2022]

In a one-year study involving adult immunodeficient patients who previously had issues with 20% SCIG products, 70% tolerated the 16.5% Cutaquig® treatment without serious adverse events, indicating it is a safer alternative.

While the mean serum IgG levels remained stable and quality of life showed some improvement, the results suggest that Cutaquig® can be a viable option for patients struggling with higher concentration SCIG products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaquig&#174; Is Well Tolerated in Immunodeficient Patients Who Did Not Tolerate Other Subcutaneous Immunoglobulin Products. Brownlee, S., Allen, C., Kana'an, MF., et al.[2022]

An 11-year-old boy with common variable immunodeficiency (CVID) and von Willebrand disease successfully transitioned from intravenous immunoglobulin (IVIG) to subcutaneous immunoglobulin (SCIG) therapy, demonstrating the feasibility of SCIG in patients with difficult intravenous access.

The patient tolerated SCIG well without experiencing any bleeding complications related to his von Willebrand disease, indicating that SCIG can be a safe and effective alternative for immunoglobulin replacement therapy in similar cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous immunoglobulin therapy in an 11-year-old patient with common variable immunodeficiency and von Willebrand disease. Arora, R., Newton, TC., Nelson, MR.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12559670/

Immunoglobulin treatment and clinical outcomes: data from ... Median time of IG therapy to discontinuation was 30 [15, 30] months. Of these SID patients, 8 (42.1%) had chronic neutrophilic bronchitis with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03018652?term=AREA%5BConditionSearch%5D(%22Lung%20Disease%22)%20AND%20AREA%5BInterventionSearch%5D(%22Rho(D)%20Immune%20Globulin%22)&rank=9

Feasibility and Safety of Immunoglobulin (Ig) Treatment in ... Patients with COPD have lower immunoglobulin G (IgG) levels compared to patients with other lung diseases, independent of oral steroid use and age. However, ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/406577

Prevalence of Humoral Dysfunction in Pts With Frequent ... COPD with pre-defined humoral dysfunction treated with subcutaneous SCIgR will have decreased AECOPD events as compared to COPD with pre-defined humoral ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11005196/

Effectiveness of immunoglobulin replacement therapy in ... It is unclear whether immune globulin replacement therapy reduces acute exacerbation frequency and severity in COPD. Current evidence suggests that it is worth ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20406207251388051

Immunoglobulin treatment and clinical outcomes Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20% in patients with primary immunodeficiency diseases in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10611600/

Real-World Use, Safety, and Patient Experience of 20% ... The CORE study aimed to provide a detailed understanding of real-world immune globulin subcutaneous (human) 20% solution (Ig20Gly) ...

7. cuvitru.com cuvitru.com/effectiveness-and-safety

CUVITRU Effectiveness & Safety In a clinical trial, CUVITRU [Immune Globulin Subcutaneous (Human)] 20% was studied in 77 people with PI ≥2 years of age in North America.