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Immunology clinical trials: Advancing autoimmune and allergy research

For the study that had no room for error,
they called Rho.
The Immune System Equation:
Decoding the Science of Immune Response
The immune system is one of the most intricate biological networks, and its role in disease is both dynamic and complex. Designing successful immunology clinical trials requires deep scientific expertise, strategic trial design, and regulatory foresight. At Rho, we bring an end-in-mind approach to immunology studies, ensuring that every step aligns with long-term regulatory and commercial success.
Why Rho?
Why Rho?
Extensive pain research expertise
Innovative trial design
Regulatory leadership
Patient-focused strategies
Spotlight: Pioneering food allergy research
The right research changes lives. Rho has been instrumental in breakthrough food allergy studies, including the landmark Learning Early About Peanut Allergy (LEAP) study. This research demonstrated that introducing peanuts early to high-risk infants dramatically reduced peanut allergy development, influencing global pediatric guidelines.
Building on that success, Rho played a key role in the OUtMATCH study, evaluating Xolair (omalizumab) for multiple food allergies. This NIH-sponsored Phase III trial led to FDA approval of Xolair, marking a major advancement in allergy treatment and giving patients new hope for safer, more flexible food choices. The impact of this study was so significant that it was recognized by National Geographic as a top scientific breakthrough, and the New England Journal of Medicine (NEJM) named it one of its top stories of 2024. It also received industry recognition with a major clinical research award.
Spotlight: Pioneering food allergy research
The right research changes lives. Rho has been instrumental in breakthrough food allergy studies, including the landmark Learning Early About Peanut Allergy (LEAP) study. This research demonstrated that introducing peanuts early to high-risk infants dramatically reduced peanut allergy development, influencing global pediatric guidelines.
Building on that success, Rho played a key role in the OUtMATCH study, evaluating Xolair (omalizumab) for multiple food allergies. This NIH-sponsored Phase III trial led to FDA approval of Xolair, marking a major advancement in allergy treatment and giving patients new hope for safer, more flexible food choices. The impact of this study was so significant that it was recognized by National Geographic as a top scientific breakthrough, and The New England Journal of Medicine (NEJM) named it one of its top stories of 2024. It also received industry recognition with a major clinical research award.
Immunology FAQ
What immunology clinical trials does Rho specialize in?
Rho supports trials across immune-mediated diseases, including autoimmune conditions, inflammatory disorders, and rare immunodeficiencies. Our expertise spans adaptive trial designs, biomarker validation, and navigating regulatory complexities for immune therapies.
What challenges are unique to immunology clinical trials?
Immunology trials face hurdles such as patient heterogeneity, complex endpoints, and high disease variability. Rho’s data-driven strategies and cross-disciplinary expertise ensure trials are optimized for actionable outcomes and regulatory acceptance.
How does Rho optimize trial design for immune therapies?
Rho integrates precision trial design with biomarker-driven insights to streamline development. Our approach focuses on robust data generation, early regulatory engagement, and innovative methodologies to advance immune therapies efficiently.
Does Rho have expertise in immune biomarker research?
Yes. Rho’s team has extensive experience with immune biomarkers, from validation to integration into trial endpoints. This ensures immune therapies are developed with precision and meet regulatory standards.
Comprehensive support for pain
clinical trials
We provide full-service support across all phases of pain research: