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Placebo and prednisone
This is a comparator arm combining placebo with prednisone, a corticosteroid that suppresses immune function and reduces inflammation.
This is a comparator arm combining placebo with prednisone, a corticosteroid that suppresses immune function and reduces inflammation. Used for Active comparator arm in phase 3 clinical trial (specific indication unknown).
At a glance
| Generic name | Placebo and prednisone |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Prednisone is a systemic corticosteroid that works by binding to glucocorticoid receptors and suppressing T-cell activation, cytokine production, and inflammatory responses. In this phase 3 trial, it serves as an active comparator control arm against which an investigational Janssen therapy is being evaluated. The placebo component indicates this is a blinded trial design.
Approved indications
- Active comparator arm in phase 3 clinical trial (specific indication unknown)
Common side effects
- Immunosuppression / increased infection risk
- Hyperglycemia
- Insomnia
- Mood changes
- Osteoporosis (with chronic use)
Key clinical trials
- Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder (EARLY_PHASE1)
- Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis (PHASE1)
- A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (PHASE3)
- An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) (PHASE3)
- A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer (PHASE3)
- A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (PHASE3)
- A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) (PHASE2)
- A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo and prednisone CI brief — competitive landscape report
- Placebo and prednisone updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI