AS012 for Vitiligo

No longer recruiting at 59 trial locations

Overseen By Head Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sun Pharma Global FZE

Disqualifiers: Segmental vitiligo, Suicidality, Alcohol abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment, AS012, for individuals with non-segmental vitiligo, a condition causing skin to lose its natural color in patches. The study compares different doses of AS012 to evaluate its effectiveness and safety. Participants will receive either one of the AS012 doses or a placebo (a pill with no active medicine). Suitable candidates have had stable or new vitiligo patches for at least a year. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AS012 is being tested for safety in people. Nearly half of the participants in earlier studies, including those who took a placebo, reported side effects. This suggests that some side effects might not be caused by AS012 itself.

Ongoing studies include safety checks and lab tests to assess how well people tolerate AS012. As this is a phase 2 trial, safety has already been reviewed in earlier studies, which typically focus on ensuring the treatment is safe for people.

In summary, while reports of side effects exist, researchers are carefully monitoring the treatment to ensure it is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for non-segmental vitiligo, like corticosteroids or topical calcineurin inhibitors, aim to reduce inflammation or modulate the immune response. But AS012 stands out as it is taken orally, offering a different delivery method compared to the usual topical applications. This could potentially lead to more comprehensive treatment effects throughout the body. Researchers are excited about AS012 because it might provide more consistent results and improve convenience for patients, possibly addressing vitiligo in areas that are hard to treat with creams.

What evidence suggests that this trial's treatments could be effective?

Research shows that AS012 might help treat non-segmental vitiligo. In earlier studies, AS012 restored skin color, which is important for treating vitiligo. This trial tests different dose regimens of AS012 to determine the most effective one. The treatment is compared to a placebo to understand its real impact. Early results suggest that AS012 could be a promising new option for people with vitiligo by potentially restoring skin color. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Stable (without new patches ≥ 1 year) or unstable (with new patches for the last 1 year) vitiligo

VASI of ≥ 4 at screening and baseline

You provide written informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AS012 or placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Long-term Follow-up

Participants are assessed for long-term outcomes and safety

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AS012
• Placebo

How Is the Trial Designed?

Group I: AS012 dose regimen IV Experimental Treatment 1 Intervention

Oral

Group II: AS012 dose regimen III Experimental Treatment 1 Intervention

Oral

Group III: AS012 dose regimen II Experimental Treatment 1 Intervention

Oral

Group IV: AS012 dose regimen I Experimental Treatment 1 Intervention

Oral

Group V: Placebo Placebo Group 1 Intervention

Oral

Who Is Running the Clinical Trial?

Sun Pharma Global FZE

Lead Sponsor

Trials

34

Recruited

10,200+

Ache Laboratorios Farmaceuticos S.A.

Lead Sponsor

Trials

34

Recruited

5,500+

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Published Research Related to This Trial

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

Adverse events (AEs) are reported in 49.1% of trial participants in placebo groups, indicating that these events are quite common and not solely due to the natural progression of conditions.

The prevalence of AEs in placebo groups (6.51%) is higher than in untreated groups (4.25%), suggesting that the nocebo effect may play a significant role in the experience of AEs during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Howick, J., Webster, R., Kirby, N., et al.[2022]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04487860

Efficacy and Safety of AS012 in Subjects With Non- ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

2. trial.medpath.com trial.medpath.com/clinical-trial/6517c5b6bec1f7b8/ctri/2021/01/030627-as012-efficacy-safety-non-segmental-vitiligo

This study is to evaluate how different doses of AS012 act in ... This study is to evaluate how different doses of AS012 act in vitiligo patients when compared with placebo. Phase 2. Active, not recruiting. Conditions.

3. withpower.com withpower.com/trial/phase-3-vitiligo-2021-5631b

Efficacy and Safety of AS012 in Subjects With Non- ... This trial is testing a new treatment to ensure unbiased results. The study is conducted across various locations and countries.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/60/NCT04487860/SAP_003.pdf

A Phase II, Randomized, Double Blind, Placebo-Controlled ... Efficacy data needs to be transposed to one record per subject structure with responses from Week 12 and Week 24 visits in different variables.

5. smartpatients.com smartpatients.com/trials/NCT04487860

Efficacy and Safety of AS012 in Subjects With Non- ... This is a randomized, double blind, placebo-controlled, phase II study. The study will be performed as a multicenter, multinational study.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/60/NCT04487860/Prot_002.pdf

A Phase II, Randomized, Double Blind, Placebo-Controlled, ... Evaluate the Efficacy and Safety of AS012 in Subjects with Non-segmental Vitiligo ... safety lab data. The access to related data will ... adverse events and ...

7. s3-us-west-1.amazonaws.com s3-us-west-1.amazonaws.com/agrian-cg-fs1-production/pdfs/Drift-Fiant_MSDS1.pdf

AS012-2 Trade Name: Drift-Fiant Chemical Family: Nonionic Su Precautionary Statements. P301+310+P330+P331: IF SWALLOWED: Wash out mouth thoroughly with water. Get medical attention. Contact a Poison Control Center.

8. fda.gov fda.gov/media/71545/download

clinical review The most frequently reported adverse reactions to the combination products of clindamycin and benzoyl peroxide are dry skin, pruritus, peeling, ...