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Monoclonal Antibodies

CFZ533 for Sjögren's Syndrome (TWINSS Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5
ESSDAI ≥ 5 within the 8 predefined organ domains
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 weeks
Awards & highlights

TWINSS Trial Summary

This trial will study a new drug to see if it is safe and effective for treating Sjögren's Syndrome, as well as how the drug works in the body.

Eligible Conditions
  • Sjögren's Syndrome

TWINSS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You experience significant fatigue or dryness, as measured by a questionnaire.
Select...
You have symptoms in at least 5 out of 8 organ areas that have been defined by the study.
Select...
You have a symptom score of 5 or higher (ESSPRI score).

TWINSS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo
Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) score from baseline at 24 weeks as compared to placebo.
Secondary outcome measures
Change from baseline in ESSDAI at Week 24
Change from baseline in ESSPRI at Week 24
Change from baseline in Physician Global Assessment (PhGA) at Week 24
+6 more

Side effects data

From 2017 Phase 1 & 2 trial • 59 Patients • NCT02217410
71%
Hypophosphataemia
57%
Nausea
43%
Dyspnoea
43%
Incision site pain
43%
Vomiting
43%
Secretion discharge
43%
BK virus infection
43%
Hyperglycaemia
29%
Diarrhoea
29%
Vitamin D deficiency
29%
Dyspepsia
29%
Hypomagnesaemia
29%
Tachycardia
29%
Hyperparathyroidism secondary
29%
Eye movement disorder
29%
Oedema peripheral
29%
Tremor
14%
Dizziness
14%
Dizziness postural
14%
Incision site erythema
14%
Acne
14%
Hyperlipidaemia
14%
Fatigue
14%
Micturition urgency
14%
Constipation
14%
Radius fracture
14%
Alopecia
14%
Complications of transplanted kidney
14%
Headache
14%
Abdominal pain
14%
Mouth ulceration
14%
Weight decreased
14%
Phonophobia
14%
Hyperkalaemia
14%
Pulmonary embolism
14%
Deep vein thrombosis
14%
Urinary tract infection
14%
Hypertension
14%
Vision blurred
14%
Pancreatitis
14%
Nocturia
14%
Photophobia
14%
Anaemia
14%
Leukocytosis
14%
Leukopenia
14%
Abdominal distension
14%
Aphthous ulcer
14%
Paraesthesia oral
14%
Generalised oedema
14%
Influenza like illness
14%
Pain
14%
Paraesthesia
14%
Hypokalaemia
14%
Anxiety
14%
Insomnia
14%
Dysuria
14%
Productive cough
14%
Wheezing
14%
Orthostatic hypotension
14%
Cardiac murmur
14%
Nasopharyngitis
14%
White blood cell count decreased
14%
Complications of transplant surgery
14%
Blood phosphorus decreased
14%
Electrocardiogram ST segment abnormal
14%
Groin pain
14%
Muscle spasms
100%
80%
60%
40%
20%
0%
Study treatment Arm
CFZ533 + TAC + MMF (Part 1)
CFZ533 + MMF (Part 2)
Tac + MMF (Part 2)
Total

TWINSS Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2/Arm F1Experimental Treatment1 Intervention
CFZ533 dose 2 (from week 24)
Group II: Cohort 2/Arm EExperimental Treatment1 Intervention
CFZ533 dose 1
Group III: Cohort 1/Arm D1Experimental Treatment1 Intervention
CFZ533 dose 1 (from week 24)
Group IV: Cohort 1/Arm CExperimental Treatment1 Intervention
CFZ533 dose 3
Group V: Cohort 1/Arm BExperimental Treatment1 Intervention
CFZ533 dose 2
Group VI: Cohort 1 /Arm AExperimental Treatment1 Intervention
CFZ533 dose 1
Group VII: Cohort 2/Arm FPlacebo Group1 Intervention
Placebo dose (up to week 24)
Group VIII: Cohort 1/Arm DPlacebo Group1 Intervention
Placebo dose (up to week 24)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CFZ533
2013
Completed Phase 2
~660

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,316 Total Patients Enrolled
6 Trials studying Sjögren's Syndrome
1,481 Patients Enrolled for Sjögren's Syndrome
Study Director Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals
2 Previous Clinical Trials
48 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment for this trial being extended?

"Unfortunately, this clinical trial has ceased recruiting patients. The study was initially posted on October 1st 2019 and the most recent update occurred November 22nd 2022. If you are searching for additional studies, there are 1386 trials presently admitting participants with sicca syndrome and 3 active CFZ533 investigations actively seeking volunteers."

Answered by AI

What potential harm can be caused by administering CFZ533?

"Considering the data from Phase 2 trials, CFZ533 is thought to be moderately safe which corresponds with a score of 2."

Answered by AI

What is the primary objective of this clinical investigation?

"This clinical study will gauge its primary outcome, Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) score from baseline at 24 weeks as compared to placebo, over a period of approximately two dozen weeks. Secondary objectives include the assessment of adverse events and serious adverse events across both cohorts, as well as an analysis of patients' responses on the Impact of Dry eye on Everyday Life (IDEEL) symptom bother module questionnaire, and change from baseline in ESSDAI scores for Cohort 2 - Efficacy Clinical Outcome Measures."

Answered by AI

Is there a widespread presence of this investigation in North America?

"This trial is currently running at 13 sites, located in Indianapolis, Mineola and Philadelphia with other nearby locations. To reduce travel constraints, it would be prudent to select the closest site for participation."

Answered by AI

Is this a pioneering or revolutionary trial?

"Presently, CFZ533 has 3 clinical trials running across 47 cities and 26 countries. Novartis Pharmaceuticals' very first trial of this drug began in 2019 with 273 participants; it was successful enough to reach the Phase 2 approval stage. Since then, a total of 18327 studies have been conducted on CFZ533."

Answered by AI

Are there still opportunities for individuals to enroll in this experiment?

"At present, this trial is not accepting new participants. The details of the study were posted on October 1st 2019 and have been recently updated as of November 22nd 2022. Alternatively, 1386 trials are actively recruiting patients with sicca syndrome while 3 studies are seeking volunteers to be treated with CFZ533."

Answered by AI

What other research endeavors have been conducted regarding CFZ533?

"Presently, three trials are ongoing for CFZ533; none of them being in the third phase. These studies are primarily based out of Boston, Massachusetts but have been extended to 150 locations nationwide."

Answered by AI
~50 spots leftby Mar 2025