DR-01 for Alopecia Areata and Vitiligo

Recruiting at 25 trial locations

Overseen By Dren Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dren Bio

Must be taking: Bimatoprost, Minoxidil

Must not be taking: JAK inhibitors, Biologics

Disqualifiers: Malignant disease, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment called DR-01, a human anti-CD94 IgG1 monoclonal antibody, for individuals with alopecia areata (a condition causing hair loss) and vitiligo (a condition causing skin to lose color in patches). Participants will receive different doses of DR-01 for up to six months, divided into groups. The study will help researchers understand the treatment's mechanism and potential side effects. It seeks adults with moderate to severe alopecia areata for more than six months or non-segmental vitiligo, meaning the condition isn't limited to one specific area. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that DR-01 is likely to be safe for humans?

Research has shown that DR-01 has been tested in patients with other conditions before. In studies involving individuals who had received extensive prior treatments, DR-01 proved to be safe and well-tolerated. Some participants experienced strong, lasting positive responses to the treatment, suggesting that DR-01 could be a promising option. However, as this is an early-stage trial for alopecia areata and vitiligo, the primary focus remains on safety. Researchers are still assessing how well participants handle the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for alopecia areata and vitiligo, which often include corticosteroids and topical immunosuppressants, DR-01 is unique because it is designed to target the underlying immune response more precisely. Researchers are excited about DR-01 because it offers a new mechanism of action that could provide more targeted and effective relief from these conditions. With multiple dosing levels being explored, DR-01 has the potential to personalize treatment to individual patient needs, potentially improving outcomes and reducing side effects compared to existing therapies.

What evidence suggests that DR-01 might be an effective treatment for Alopecia Areata and Vitiligo?

Research shows that DR-01 targets a part of certain immune cells, such as CD8+ T cells, which play a role in the body's defense system. These cells can influence conditions like alopecia areata and vitiligo. A similar treatment targeting another part of immune cells has helped some people with vitiligo, suggesting that DR-01 might also be beneficial. Although specific results for DR-01 in these skin conditions are not yet available, its action on immune cells suggests potential for managing them. Early studies in other diseases have shown promising results, encouraging further research into its effectiveness. Participants in this trial will receive DR-01 at different dose levels to evaluate its potential benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Rothenberg, MD, PhD

Principal Investigator

Dren Bio

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• DR-01

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

Adalimumab, an anti-TNF-alpha monoclonal antibody used for conditions like rheumatoid arthritis and psoriasis, was associated with the development of alopecia areata universalis in a patient six months after treatment.

The scalp biopsy revealed a significant immune response involving T cells and macrophages, suggesting that TNF-alpha may play a complex role in triggering alopecia areata, highlighting the need for careful monitoring of immune-related side effects in patients receiving this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alopecia areata universalis elicited during treatment with adalimumab. Pelivani, N., Hassan, AS., Braathen, LR., et al.[2015]

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]

The study found a significant association between hepatitis B virus (HBV) vaccination and an increased frequency of alopecia areata (AA) in pediatric patients, with an odds ratio of 2.7, indicating a potential link between the vaccine and the autoimmune condition.

Additionally, the research identified a higher occurrence of AA in patients receiving interferon (IFN-β) treatment, with an odds ratio of 8.1, suggesting that both viral infections and certain treatments may contribute to the development of AA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Relationship between Alopecia Areata and Viral Antigen Exposure. Richardson, CT., Hayden, MS., Gilmore, ES., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-1-vitiligo-8-2024-1c37f

DR-01 for 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06602232

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

3. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper206053.html

980 Results from the First Phase 1 Clinical Study of DR-01, ... DR-01 is a non-fucosylated human IgG antibody targeting CD94, a receptor selectively expressed on cytotoxic terminal effector CD8+T cells, γδT cells, and NK ...

4. bloodcancerunited.org bloodcancerunited.org/research/award/phase-12-study-dr-01-anti-cd94-monoclonal-antibody-patients-large-granular

A phase 1/2 study of DR-01, an anti-CD94 monoclonal ... A Phase 1/2 trial is ongoing to assess the safety and efficacy of DR-01 in previously treated LGLL patients and cytotoxic lymphomas (NCT05475925) ...

5. youtube.com youtube.com/watch?v=WN4U-NrCeqU

DR-01, an anti-CD94 monoclonal antibody, in the treatment of ... Prof. Iyer notes that DR-01 has shown promising results in a Phase I ... trial is now being considered as a registration study looking ...

6. synapse.patsnap.com synapse.patsnap.com/organization/0a5f0c80a0329b5822decdd584f31422

Dren Bio, Inc. - Drug pipelines, Patents, Clinical trials Conclusion: DR-01 is safe and tolerable in heavily pretreated patients. An encouraging response rate including 3 durable CRs points to the potential for DR-01 ...