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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical study to investigate the safety of DEN-181 in rheumatoid arthritis patients
Scientific title
A Phase I, randomised, double-blind, placebo-controlled, single centre, single-dose escalation study to investigate the safety, tolerability, and pharmacodynamics of subcutaneously administered DEN-181 in adult patients with ACPA+ rheumatoid arthritis on stable treatment with methotrexate.
Secondary ID [1] 292591 0
Dendright Pty Ltd
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 304263 0
Condition category
Condition code
Inflammatory and Immune System 303613 303613 0 0
Rheumatoid arthritis

Study type
Description of intervention(s) / exposure
Randomised double blind, placebo-controlled, single centre, single-dose escalation study of DEN-181 at three dose levels (4 active, 2 placebo per dose level).
DEN-181 is a liposomal formulation encapsulating two active pharmaceutical ingredients, calcitriol (0.6 ug/mL) and collagen II peptide (42 ug/mL; 15 amino acid peptide corresponding to collagen II protein 259-273 (Proline 273 Hydroxyproline substitution).
DEN-181 is given by subcutaneous injection at a volume of 100 uL, 300 uL or 1000 uL.

Intervention code [1] 298800 0
Treatment: Drugs
Comparator / control treatment
Study is placebo controlled. Placebo is sterile saline for injection (0.9% NaCl). Background therapy is methotrexate.
Control group

Primary outcome [1] 302968 0
Clinical safety observations including changes in:
Vital signs,
Symptom directed physical examination,
Adverse events (graded according to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03)),
Laboratory abnormalities (Haematology including ESR and Clinical chemistry including CRP in serum samples),
Timepoint [1] 302968 0
For 56 days after administration of a single dose of DEN-181.
All primary safety assessments are to be performed on day 1, 8, 15, 29, 57.
Secondary outcome [1] 337590 0
Proportion and total number of naïve, effector and regulatory T-cells by flow cytometry (composite outcome)

Timepoint [1] 337590 0
Assessment of the proportion, total number and phenotype of naïve, effector and regulatory T-cells will be conducted on day Day 1, 8 and 29.
Secondary outcome [2] 339520 0
Determination of the concentration of calcitriol in plasma samples.
Timepoint [2] 339520 0
Assessment of plasma calcitriol will performed on day 1.
Secondary outcome [3] 339521 0
Mean changes in DAS28CRPv4 (Disease Activity Score 28 including CRP assessment 4 variable calculation) scoring system.
Timepoint [3] 339521 0
Assessment of DAS28CRPv4 score will be performed on day 1, 8, 15, 29, 57.
Secondary outcome [4] 339840 0
Phenotype of naïve, effector and regulatory T-cells by flow cytometry
Timepoint [4] 339840 0
Assessment of the phenotype of naïve, effector and regulatory T-cells will be conducted on day Day 1, 8 and 29.

Key inclusion criteria
The criteria for entry into the study are:
1. Diagnosis of rheumatoid arthritis made by a rheumatologist;
2. HLA-DRB1*0401+, HLA-DRB1*0101+ or HLA-DRB1*0401+HLA-DRB1*0101+ heterozygotes, homozygotes or compound heterozygotes; and ACPA+ (anti-CCP2>6);
3. Treatment with MTX at the same dose for at least 4 weeks prior to planned start of trial treatment;
4. Age 18-75 years (male or female) inclusive;
5. Patients must be informed of the investigational nature of this study and give voluntary written informed consent in accordance with the institutional and hospital guidelines;
6. With or without swollen joints;
7. Male or Female. Females of child-bearing potential must agree to use two effective forms of contraception from enrolment to completion of the study;
8. Blood glucose, CBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT not greater than 1.5 times out of normal range at entry and clinically insignificant in the opinion of the investigator;
9. Patients agree to forego vaccinations during the course of the study;
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
The criteria for exclusion from the study are:
1. Malignancy;
2. An active inflammatory disease other than RA;
3. Currently receiving or have received treatment with >10mg prednisone daily within the last 2 weeks prior to screening;
4. Current or recent treatment (< 2 weeks prior) with any disease-modifying anti- rheumatic drugs other than methotrexate;
5. Serious infection requiring hospitalization within last 28 days;
6. Receipt of any live attenuated vaccines within 4 weeks prior to entry;
7. Major surgery within last 28 days;
8. Significant cardiovascular, renal, liver, neurological or skin disease;
9. Positive serology for HIV or infection with HBV or HCV;
10. Treatment with cytotoxic or immunomodulatory therapies such as radiotherapy, cyclophosphamide, mycophenolate, tacrolimus, PUVA, acitretin, cyclosporine or azathioprine;
11. Any known or suspected allergies to the study drug or its constituents including egg products;
12. Inadequate venous access to allow collection of blood samples;
13. History of drug or alcohol abuse;
14. Participation in another clinical study;
15. If, in the opinion of the PI, the subject appears not to be able to perform the needed responsibilities of participation in the clinical study.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation.
A randomisation scheme will be prepared in advance by the study statistician using a computer generated system according to relevant SOPs.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis
No formal sample size calculations were performed for this study.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 8689 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 16800 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297169 0
Commercial sector/Industry
Name [1] 297169 0
Dendright Pty Ltd
Address [1] 297169 0
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country [1] 297169 0
Funding source category [2] 297170 0
Name [2] 297170 0
Arthritis Queensland
Address [2] 297170 0
1 Cartwright Street (Cnr Lutwyche Road)
Country [2] 297170 0
Primary sponsor type
Commercial sector/Industry
Dendright Pty Ltd
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Secondary sponsor category [1] 296188 0
Name [1] 296188 0
Address [1] 296188 0
Country [1] 296188 0

Ethics approval
Ethics application status
Ethics committee name [1] 298337 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 298337 0
PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 298337 0
Date submitted for ethics approval [1] 298337 0
Approval date [1] 298337 0
Ethics approval number [1] 298337 0

Brief summary
Current treatments to control damaging immune responses during autoimmunity use broad immunosuppressive drugs associated with undesirable side effects. Alternative strategies to control damaging immune responses are desirable. DEN-181 offers a novel liposomal therapy that does not broadly suppress the immune system, with the associated increased risk of infectious complications, but rather is designed to specifically address the underlying pathology of Rheumatoid Arthritis by re-programming the immune system towards tolerance for improved patient outcomes and minimal side effects. This study is designed to assess the safety and tolerability of a single dose of DEN-181 in Rheumatoid Arthritis patients.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 76758 0
Dr Phillip Vecchio
Address 76758 0
Princess Alexandra Hospital
Ipswich Road
Country 76758 0
Phone 76758 0
+61 7 3391 7500
Fax 76758 0
+61 7 3176 7131
Email 76758 0
Contact person for public queries
Name 76759 0
Ms Joanna Tesiram
Address 76759 0
Clinical Nurse - Biologics/Clinical Trials Coordinator/Clinical Research Nurse Rheumatology Unit |
Division of Medicine
Princess Alexandra Hospital
Metro South Health
199 Ipswich Road
Woolloongabba QLD 4102
Country 76759 0
Phone 76759 0
+61 7 3176 2163
Fax 76759 0
+61 7 3240 7131
Email 76759 0
Contact person for scientific queries
Name 76760 0
Ms Helen Roberts
Address 76760 0
Dendright Pty Ltd
6NE.6006 Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country 76760 0
Phone 76760 0
+61 (0) 419 657 504
Fax 76760 0
Email 76760 0

No information has been provided regarding IPD availability
Summary results
No Results