Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients

NCT03814746 · STAND Phase 3Active, not recruiting

Lead sponsor: Novartis Pharmaceuticals (Industry)
Enrollment: 253 (actual)
Start date: 26 Jul 2019
Primary completion: 31 Aug 2022 (actual)
Study completion: 5 Nov 2026
Last update posted: 14 Oct 2026

Design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel
Masking: Quadruple
Arms: 3

Interventions

Crizanlizumab (SEG101) Drug
Placebo Drug

Conditions and primary outcome

Sickle Cell Disease (SCD)

Primary outcome

Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit (1 year)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03814746 (opens in a new tab)· Licence: public-domain

First posted 8 Jan 2024 · Last update posted 14 Oct 2026 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit
Time frame
1 year
Measure
Mean
Unit
number of events per year
- Crizanlizumab (SEG101) at 5.0 mg/kg vs PlaceboSuperiority
  Estimate
  1.08Rate ratio
  95% CI, two-sided
  0.76 to 1.55
  p-value
  > 0.999
  Method
  negative binomial regression model
- Crizanlizumab (SEG101) at 7.5 mg/kg vs PlaceboSuperiority
  Estimate
  0.89Rate ratio
  95% CI, two-sided
  0.62 to 1.27
  p-value
  > 0.999
  Method
  negative binomial regression model

Serious adverse events

Time frame: This primary analysis report includes data with a cut-off date 31-Aug-2022. Adverse events and deaths were collected from first dose of study treatment to105 days post-last infusion (defined as on-treatment), up to max on-treatment period of approx. 5 years.

Participants with serious adverse events per group for STAND, as posted
Group	Affected	At risk
Crizanlizumab (SEG101) at 5.0 mg/kg (On-treatment)	35	84
Crizanlizumab (SEG101) at 7.5 mg/kg (On-treatment)	22	83
Placebo (On-treatment)	26	85

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

Crizanlizumab with or without hydroxyurea in patients with sickle cell disease (STAND): primary analyses from a placebo-controlled, randomised, double-blind, phase 3 trial.
The Lancet. Haematology · 2025 Apr
PubMed 40088922 (opens in a new tab)DOI 10.1016/S2352-3026(24)00384-3 (opens in a new tab)
Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations.
Kidney360 · 2023 Jul 1
PubMed 37254256 (opens in a new tab)DOI 10.34067/KID.0000000000000162 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

About CT-VCA

Loading CT-VCA scores…

Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Crizanlizumab

Source

NCT03814746 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.