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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06647069




Registration number
NCT06647069
Ethics application status
Date submitted
16/10/2024
Date registered
17/10/2024

Titles & IDs
Public title
DR-0201 in Subjects With Autoimmune Diseases
Scientific title
A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of DR-0201 in Patients With Select Autoimmune Rheumatic Diseases
Secondary ID [1] 0 0
DR-0201-AIM-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SLE 0 0
SLE (Systemic Lupus) 0 0
CLE 0 0
Cutaneous Lupus 0 0
Sjogren's Syndrome 0 0
Primary Sjögren Syndrome 0 0
Dermatomyositis 0 0
Polymyositis 0 0
Scleroderma 0 0
SSc, Diffuse Sclerosis 0 0
dcSSc 0 0
Diffuse Cutaneous Systemic Sclerosis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DR-0201

Experimental: DL1 of DR-0201 - Subjects in this arm will receive up to 7 months of dosing with dose level 1 of DR-0201

Experimental: DL2 of DR-0201 - Subjects in this arm will receive up to 7 months of dosing with dose level 2 of DR-0201

Experimental: DL3 of DR-0201 - Subjects in this arm will receive up to 7 months of dosing with dose level 3 of DR-0201

Experimental: DL4 of DR-0201 - Subjects in this arm will receive up to 7 months of dosing with dose level 4 of DR-0201

Experimental: DL5 of DR-0201 - Subjects in this arm will receive up to 7 months of dosing with dose level 5 of DR-0201

Experimental: DL6 of DR-0201 - Subjects in this arm will receive up to 7 months of dosing with dose level 6 of DR-0201


Treatment: Drugs: DR-0201
DR-0201 is a bispecific antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events as assessed by CTCAE v5.0.(Safety and Tolerability)
Timepoint [1] 0 0
Baseline to Day 239

Eligibility
Key inclusion criteria
1. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnosis of 1 of the following active autoimmune diseases: SLE or CLE (both must have CLASI > 8 at both screening and baseline visits); pSS; PM/DM (probable or definite); and/or dcSSc (of < 3 years duration).
2. Subjects with SLE, CLE, or dcSSc must be willing to undergo skin biopsies at baseline and 2 skin biopsies during the treatment period; subjects with pSS must be willing to undergo salivary gland biopsies at baseline and 2 salivary gland biopsies during the treatment period; subjects with PM must be willing to undergo muscle biopsies at baseline and 2 muscle biopsies during the treatment period; and subjects with DM must be willing to undergo muscle biopsies at baseline and 2 muscle biopsies during the treatment period or they may choose to undergo skin biopsies instead.
3. Between 18 and 75 years of age, inclusive, of either gender and of any race.
4. Stable, but active disease, such that in the opinion of the Investigator, it is unlikely that a change in the subject's therapeutic regimen would be required during the subsequent 3 to 4 months.
5. Photographs of skin lesions, when applicable, must be submitted for review to confirm that the lesions are suitable for punch biopsy and caused by SLE, CLE, or DM disease activity. Such confirmation by the Sponsor must be received prior to enrollment.
6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
7. Use of a highly effective contraceptive measure (< 1% failure rate; see Section 13.1) for all non-sterilized males and all females of childbearing potential during study through 120 days after last DR-0201 dose. Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to the first dose of DR-0201. Females who are not of childbearing potential (i.e., who are considered to be post-menopausal [= 12 months of non-therapy amenorrhea] or surgically sterile [absence of ovaries and/or uterus]) are not required to have a pregnancy test or use contraception.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD.
2. Receipt of super-high potency (e.g., clobetasol propionate) or high potency (e.g., fluocinonide) topical corticosteroids within 1 month prior to screening.
3. Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or nonsteroidal topical immunosuppressants within 28 days prior to Day 1 or dose changes of oral or topical corticosteroids within 14 days prior to Day 1.
4. Required regular use of medications known to cause, as a major side effect, dry mouth/eyes, and which have not been on a stable dose for at least 30 days prior to screening, or any anticipated change in the treatment regimen during the course of the study.
5. Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide > 20 mg/day, abatacept.
6. Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is shorter.
7. Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.
8. Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN.
9. Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, chimeric antigen receptor T cell (CAR-T) or T cell vaccination therapy.
10. Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, positive result for HIV infection, splenectomy, or any underlying condition that predisposes the subject to infection.
11. Subjects with AST > 2.5 × upper limit of normal (ULN), ALT > 2.5 × ULN, total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome), total immunoglobulin < 500 g/dL, neutrophil count < 1000/µL, platelet count < 85,000/µL, hemoglobin < 10 g/dL, glycosylated hemoglobin > 8%, total lymphocyte count < 300/µL, or glomerular filtration rate < 50 mL/min/1.73 m2.
12. History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
13. Active infection or a history of serious infections as follows:

1. Use of antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) for an infection within 30 days prior to the first dose of DR-0201. Topical treatments may be allowed at the Medical Monitor's discretion.
2. History of opportunistic infections in the last 2 years.
3. Recurrent or chronic infection, or other active infection, that in the opinion of the Investigator might cause this study to be detrimental to the subject.
4. Symptomatic herpes zoster within 3 months prior to screening or recurrent herpes zoster or herpes simplex infections.
5. History of tuberculosis (active or latent) irrespective of treatment status.
6. Any history of viral hepatitis: hepatitis B virus, hepatitis C virus (HCV), hepatitis E virus. HCV is acceptable if HCV ribonucleic acid (RNA) is undetectable for at least 3 months after completion of direct-acting antiviral therapy.
14. Major surgery within 28 days prior to Day 1.
15. QT interval corrected for heart rate (QTc) > 480 msec, based on the mean of triplicate ECGs. The QTc is the QT interval corrected using Fridericia's formula (QTcF).
16. Evidence of significant, uncontrolled concurrent disease that could affect compliance with the study(e.g., chronic obstructive pulmonary disease).
17. Previous exposure to DR-0201.
18. Participation in a clinical trial and has received an investigational product within the following time period prior to screening in the current study: 3 months (for biologic therapies) or 1 month (for non-biologic therapies), 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
19. Unstable lifestyle factors (including but not limited to excessive alcohol use, heavy nicotine use, or substance abuse), to the extent that, in the opinion of the Investigator, they would interfere with the ability of a subject to complete the study.
20. Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Dren Investigational Site - Adelaide
Recruitment hospital [2] 0 0
Dren Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Bosnia and Herzegovina
State/province [1] 0 0
Mostar
Country [2] 0 0
Bosnia and Herzegovina
State/province [2] 0 0
Sarajevo
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Plovdiv
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
South Africa
State/province [5] 0 0
Polokwane
Country [6] 0 0
South Africa
State/province [6] 0 0
Pretoria
Country [7] 0 0
South Africa
State/province [7] 0 0
Waltloo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dren Bio
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Rothenberg, MD, PhD
Address 0 0
Dren Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dren Central Contact
Address 0 0
Country 0 0
Phone 0 0
415-737-5277
Fax 0 0
Email 0 0
clinops@drenbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06647069