Last reviewed · How we verify
Placebo for Risankizumab SC
Placebo for Risankizumab SC is a Small molecule drug developed by AbbVie. It is currently in Phase 3 development for Control arm in risankizumab phase 3 trials (likely psoriasis, Crohn's disease, or ulcerative colitis based on risankizumab's development program).
This is a placebo control used in clinical trials to compare against risankizumab, an IL-23 inhibitor.
This is a placebo control used in clinical trials to compare against risankizumab, an IL-23 inhibitor. Used for Control arm in risankizumab phase 3 trials (likely psoriasis, Crohn's disease, or ulcerative colitis based on risankizumab's development program).
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
AbbVie is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Placebo for Risankizumab SC |
|---|---|
| Sponsor | AbbVie |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Placebo contains no active pharmaceutical ingredient and serves as the control arm in phase 3 trials of risankizumab subcutaneous formulation. It allows researchers to isolate the true therapeutic effect of risankizumab by comparing patient outcomes between the active drug and an inert comparator administered via the same route.
Approved indications
- Control arm in risankizumab phase 3 trials (likely psoriasis, Crohn's disease, or ulcerative colitis based on risankizumab's development program)
Common side effects
Key clinical trials
- A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (PHASE3)
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. (PHASE3)
- A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (PHASE3)
- A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease (PHASE3)
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE2, PHASE3)
- Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement (PHASE3)
- A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (PHASE2)
- A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease (PHASE3)
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 for Risankizumab SC CI brief — competitive landscape report
- Placebo for Risankizumab SC updates RSS · CI watch RSS
- AbbVie portfolio CI
Frequently asked questions about Placebo for Risankizumab SC
What is Placebo for Risankizumab SC?
How does Placebo for Risankizumab SC work?
What is Placebo for Risankizumab SC used for?
Who makes Placebo for Risankizumab SC?
What development phase is Placebo for Risankizumab SC in?
Related
- Manufacturer: AbbVie — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Control arm in risankizumab phase 3 trials (likely psoriasis, Crohn's disease, or ulcerative colitis based on risankizumab's development program)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing