DR-01 for Alopecia Areata and Vitiligo

Recruiting at 24 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Dren Bio

Must be taking: Bimatoprost, Minoxidil

Must not be taking: JAK inhibitors, Biologics

Disqualifiers: Malignant disease, Autoimmune diseases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.

Will I have to stop taking my current medications?

The trial requires that you do not start new medications or change dosages for any existing medications for reasons other than vitiligo. You must stay on a stable medication regimen during the study. Additionally, certain medications like JAK inhibitors, lymphocyte depleting agents, and oral immune suppressants must be stopped before the trial.

What data supports the effectiveness of the drug DR-01 for treating alopecia areata and vitiligo?

There is no direct data on DR-01, but a study on a similar treatment using a monoclonal antibody to CD20 showed improvement in some vitiligo patients. This suggests that targeting immune cells with antibodies might help in treating these conditions. ^{1 2 3 4 5}

How is the drug DR-01 unique for treating alopecia areata and vitiligo?

DR-01 is a novel treatment because it is a human anti-CD94 IgG1 monoclonal antibody, which targets specific immune cells involved in the autoimmune response, potentially offering a new mechanism of action compared to existing treatments for alopecia areata and vitiligo. ^{3 4 5 6 7}

Research Team

Michael Rothenberg, MD, PhD

Principal Investigator

Dren Bio

Eligibility Criteria

This trial is for adults with Alopecia Areata or Vitiligo. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

Agree to not use adhesive wigs during the study

Agree not to use any AA treatments during the study

Women of childbearing potential must agree to use a highly effective method of contraception

Exclusion Criteria

Intolerance or allergy to the investigational product or any of its components

Specific exclusion criteria for Alopecia Areata and Vitiligo

Known history of chronic alcohol abuse, IV drug abuse or illicit drug abuse within 1 year before screening

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DR-01 at various dose levels for up to 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DR-01 (Cancer Vaccine)

Trial Overview The study tests DR-01's safety, effectiveness, and how the body processes it in patients with Alopecia Areata or Vitiligo. It's an early-phase trial (Phase 1b), meaning it's one of the first times this drug is being tested in humans.

Participant Groups

Group I: DL4 of DR-01 Experimental Treatment 1 Intervention

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 4

Group II: DL3 of DR-01 Experimental Treatment 1 Intervention

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 3

Group III: DL2 of DR-01 Experimental Treatment 1 Intervention

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 2

Group IV: DL1 of DR-01 Experimental Treatment 1 Intervention

Subjects in this arm will receive up to 6 months of dosing with DR-01 at dose level 1

Who Is Running the Clinical Trial?

Dren Bio

Lead Sponsor

Trials

6

Recruited

280+

Findings from Research

In a study involving 9 patients with alopecia areata and alopecia universalis, as well as 6 patients with psoriasis, a higher proportion of T lymphocytes with Fc receptors for IgG (Tg cells) was found in those with alopecia and psoriasis compared to normal donors.

Despite the increased Tg cells, the overall proportions of total T lymphocytes and other specific T cell subpopulations were within normal ranges, suggesting a complex immune response in these conditions that may involve different T cell subpopulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T lymphocyte subpopulations in alopecia areata and psoriasis: identification with monoclonal antibodies and Fc receptors. Gu, SQ., Petrini, B., Ros, AM., et al.[2006]

In patients with alopecia areata (AA), specific synthetic epitopes from hair follicle antigens trichohyalin and tyrosinase-related protein-2 triggered a stronger immune response in cytotoxic T cells compared to healthy individuals, indicating a potential mechanism for the autoimmune nature of the disease.

The study found that activated T cells from AA patients released factors that increased apoptosis in hair follicle keratinocytes, suggesting that the immune response to these self-antigens could serve as a prognostic marker for the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Autoantigen Epitopes in Alopecia Areata. Wang, EHC., Yu, M., Breitkopf, T., et al.[2022]

In a small study of five patients with active disseminated vitiligo, a single intravenous infusion of a chimeric monoclonal antibody to CD20 resulted in significant clinical and histological improvement in three patients, indicating potential efficacy of this treatment.

The observed improvements were not linked to changes in laboratory parameters or specific HLA-DR phenotypes, suggesting that further research is needed to identify reliable markers for response to this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of vitiligo with a chimeric monoclonal antibody to CD20: a pilot study. Ruiz-Argüelles, A., García-Carrasco, M., Jimenez-Brito, G., et al.[2023]

In a study of 27 patients with alopecia areata or totalis, 9 showed antibody reactivity to melanocyte-derived cells, indicating an autoimmune response that may contribute to hair loss.

The study found distinct antibody profiles between alopecia areata and vitiligo patients, with specific antigens (74,500 and 70,800 mol wt) being more prevalent in alopecia areata, particularly in those with total hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Western blot analysis of serum antibody reactivity with human melanoma cell antigens in alopecia areata and vitiligo. Galbraith, GM., Miller, D., Emerson, DL.[2019]

In a study of 48 patients with vitiligo, 14 with alopecia areata, and 35 normal controls, 92% of vitiligo patients showed antibodies against human melanoma cells, indicating a strong autoimmune response associated with vitiligo.

The antibodies were primarily directed at specific antigens (110 KD, 88 KD, and 70 KD), suggesting that the immune response in vitiligo may be a secondary reaction to the destruction of pigment cells, while no significant differences were found in antibody presence between alopecia areata patients and normal controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of antibodies to human melanoma cells in vitiligo and alopecia areata by Western blot analysis. Hann, SK., Koo, SW., Kim, JB., et al.[2006]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

T lymphocyte subpopulations in alopecia areata and psoriasis: identification with monoclonal antibodies and Fc receptors. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Identification of Autoantigen Epitopes in Alopecia Areata. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of vitiligo with a chimeric monoclonal antibody to CD20: a pilot study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Western blot analysis of serum antibody reactivity with human melanoma cell antigens in alopecia areata and vitiligo. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Detection of antibodies to human melanoma cells in vitiligo and alopecia areata by Western blot analysis. [2006]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of the Relationship between Alopecia Areata and Viral Antigen Exposure. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Alopecia areata universalis elicited during treatment with adalimumab. [2015]