Solriktug for Asthma

(RAINIER Trial)

Recruiting at 28 trial locations

Overseen By Anushri Walsh

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Uniquity One (UNI)

Must be taking: Inhaled corticosteroids, Long-acting beta agonists

Disqualifiers: Pregnancy, Smoking, Cardiovascular, Pulmonary, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

124 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires participants to continue their current asthma medications, such as inhaled corticosteroids and long-acting beta agonists, for at least 3 months before joining the study.

What data supports the effectiveness of the drug Solriktug for asthma?

The research highlights the benefits of a multidisciplinary approach in managing severe asthma, which includes medication optimization and improved patient self-management, leading to better outcomes like reduced hospitalizations and exacerbations. While Solriktug is not specifically mentioned, similar comprehensive care strategies have shown positive results in asthma management. ^{1 2 3 4 5}

Is Solriktug safe for humans?

There is no specific safety data available for Solriktug, but similar asthma treatments have shown reassuring safety profiles when used with inhaled corticosteroids, although some serious side effects have been noted when used alone. ^{6 7 8 9 10}

What is the purpose of this trial?

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.

Research Team

Andrew W Lee, MD

Principal Investigator

Vice President, Clinical Research

Eligibility Criteria

Adults with asthma are eligible for this trial. Specific details about who can join or reasons why someone might not be able to participate (inclusion and exclusion criteria) were not provided.

Inclusion Criteria

My asthma improves significantly after using a bronchodilator.

I have been on asthma medication for at least 3 months.

I was diagnosed with asthma over a year ago.

Exclusion Criteria

I currently smoke or have smoked at least 10 pack-years.

I have a significant lung condition other than asthma.

I am currently pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive solrikitug or placebo via subcutaneous injection over a 12-week period

12 weeks

Weekly visits (in-person) for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Solriktug

Trial Overview The study is testing three different doses of a biological drug called Solriktug against a placebo to assess its safety, how the body processes it, immune response, and effects on asthma.

Participant Groups

Group I: Solrikitug mid dose subcutaneous injection Experimental Treatment 1 Intervention

Solrikitug

Group II: Solrikitug low dose subcutaneous injection Experimental Treatment 1 Intervention

Solrikitug

Group III: Solrikitug high dose subcutaneous injection Experimental Treatment 1 Intervention

Solrikitug

Group IV: Placebo subcutaneous injection Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Uniquity One (UNI)

Lead Sponsor

Trials

5

Recruited

490+

DevPro Biopharma

Collaborator

Trials

5

Recruited

800+

DevPro Biopharma

Industry Sponsor

Trials

5

Recruited

800+

Findings from Research

A systematic and multidimensional day case assessment for patients with severe asthma, involving a multidisciplinary team, leads to improved patient outcomes such as better diagnosis, medication optimization, and reduced corticosteroid use.

Patients reported a significantly enhanced experience, feeling more listened to and empowered, which contributes to their overall psychological well-being and hope for the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The multidisciplinary team severe asthma day case assessment and its impact on patient care. Holmes, LJ., Sheehan, R., Elsey, L., et al.[2021]

In a study of 51 severe asthma patients, only 25.5% achieved adequate symptom control after a systematic treatment protocol involving oral corticosteroids and budesonide/formoterol, highlighting the challenges in managing severe asthma.

Despite the low control rate, the treatment protocol improved health-related quality of life and reduced asthma control questionnaire scores, suggesting that a structured approach can benefit some patients and potentially reduce the need for more complex therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can severe asthmatic patients achieve asthma control? A systematic approach in patients with difficult to control asthma followed in a specialized clinic. Athanazio, R., Carvalho-Pinto, R., Fernandes, FL., et al.[2018]

Establishing treatment goals for pediatric asthma that align with both patients and caregivers is crucial for long-term control, as differing perceptions can hinder effective management.

Objective measures of airway inflammation, such as exhaled nitric oxide analysis, are essential for assessing asthma severity and guiding treatment strategies, helping to ensure that both patients and caregivers understand the importance of anti-inflammatory treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges to treatment goals and outcomes in pediatric asthma. Becker, AB.[2019]

Asthma management is generally effective when patients adhere moderately to their treatment plans, but the small benefits of interventions require large sample sizes to detect meaningful outcomes in research.

To accurately assess asthma outcomes, researchers should use a combination of asthma-specific measures (like symptoms of coughing and wheezing) and generic measures, while avoiding generic measures designed for severely debilitating diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures of life quality, role performance, and functional status in asthma research. Richards, JM., Hemstreet, MP.[2022]

Patient education significantly improved health-related quality of life (HRQoL) and lung function (FEV1) in asthma patients after 12 months, with notable improvements in symptoms and activity scores as measured by the St. George's Respiratory Questionnaire (SGRQ).

In contrast, the same educational intervention did not yield significant improvements in HRQoL or lung function for patients with Chronic Obstructive Pulmonary Disease (COPD), indicating that the benefits of patient education may vary between these two respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life assessment after patient education in a randomized controlled study on asthma and chronic obstructive pulmonary disease. Gallefoss, F., Bakke, PS., Rsgaard, PK.[2015]

A systematic review of 21 studies involving 11,572 adults and adolescents found no significant difference in safety profiles between regular formoterol combined with inhaled corticosteroids and salmeterol combined with inhaled corticosteroids for asthma treatment.

While five deaths were reported across all studies, none were attributed to asthma, indicating that both treatment options are generally safe, but the evidence is insufficient to draw firm conclusions about their relative risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events. O'Shea, O., Stovold, E., Cates, CJ.[2022]

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

In a comprehensive analysis of 79 randomized controlled trials involving 94,684 patients, there was no increase in asthma-related deaths among those treated with formoterol compared to non-LABA treatments, suggesting that formoterol is a safe option for asthma management.

Formoterol significantly reduced nonfatal asthma-related serious adverse events (relative risk 0.63) and led to fewer discontinuations due to adverse events, indicating its efficacy in improving asthma control while maintaining safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of formoterol in asthma clinical trials: an update. Sears, MR., Radner, F.[2015]

Newer anti-inflammatory medications for asthma show promising therapeutic benefits and have safer profiles compared to traditional treatments, which often come with significant side effects.

The ongoing challenge in asthma management is to effectively integrate these newer therapies into treatment plans to maximize benefits while minimizing adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New medications for asthma. Cydulka, RK., Jarvis, HE.[2019]

In a study involving 472 asthmatics treated with fluticasone/formoterol for up to 12 months, the therapy demonstrated a good safety profile, with only 3.8% of patients reporting adverse events related to the medication.

Efficacy results showed significant improvements in asthma control at all time points, indicating that fluticasone/formoterol is effective for managing asthma symptoms over the study duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. Mansur, AH., Kaiser, K.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

The multidisciplinary team severe asthma day case assessment and its impact on patient care. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Can severe asthmatic patients achieve asthma control? A systematic approach in patients with difficult to control asthma followed in a specialized clinic. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Challenges to treatment goals and outcomes in pediatric asthma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Measures of life quality, role performance, and functional status in asthma research. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Quality of life assessment after patient education in a randomized controlled study on asthma and chronic obstructive pulmonary disease. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Safety of formoterol in asthma clinical trials: an update. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

New medications for asthma. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. [2018]