SCD-044 for Eczema

(SOLARES-AD-1 Trial)

Recruiting at 85 trial locations

Overseen By Head, Clinical development

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sun Pharmaceutical Industries Limited

Disqualifiers: Pregnancy, Diabetes complications, Uveitis

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

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called SCD-044 for individuals with moderate to severe eczema, a skin condition causing itchy and inflamed patches. The study compares different doses of SCD-044 to assess their effectiveness and safety, using a placebo (a non-active pill) for comparison. It seeks participants who have experienced eczema for at least a year and find it significantly impacts their daily life. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

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 SCD-044, also known as Vibozilimod, has been tested for safety in treating conditions like eczema and psoriasis. Participants in these studies generally tolerated the treatment well. Some might experience mild side effects, but no serious problems have been reported as caused by the drug.

It is important to know that SCD-044 is still undergoing tests to assess both its safety and effectiveness. While earlier research suggests it appears safe, further testing is necessary to confirm this. Prospective participants should consider discussing any concerns with a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about SCD-044 for eczema because it offers a potentially new approach to treating moderate to severe atopic dermatitis. While most current treatments, like topical steroids and calcineurin inhibitors, focus on reducing inflammation on the skin's surface, SCD-044 is believed to work differently by targeting specific pathways involved in the inflammatory process from within. This oral medication comes in three different doses, allowing for flexibility in managing the severity of the condition. By potentially addressing the root cause of inflammation, SCD-044 could offer an effective alternative to existing therapies.

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

Research has shown that SCD-044 was tested for other skin conditions like psoriasis, but the results were not encouraging. Studies found it did not work well, leading to the discontinuation of its development for psoriasis. For eczema, also known as atopic dermatitis, information is less clear. However, early findings from similar treatments suggest that SCD-044 might help improve skin symptoms. Because past trials did not provide strong evidence, its effectiveness for eczema remains uncertain. This trial will test different doses of SCD-044, alongside a placebo, to gather clearer data on its effects on eczema. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe atopic dermatitis (eczema) that's been diagnosed for at least a year. It's not open to pregnant or nursing women, those planning pregnancy soon, or individuals with complications from diabetes like kidney issues, eye problems, or neuropathy.

Inclusion Criteria

I have had chronic atopic dermatitis for over a year.

I have moderate to severe eczema.

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant soon.

I have diabetes-related complications like kidney issues, eye problems, or nerve damage.

I have had or currently have uveitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SCD-044 or placebo tablets for the treatment of moderate to severe atopic dermatitis

32 weeks

Regular visits for assessment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SCD-044_Dose 1
• SCD-044_Dose 2
• SCD-044_Dose 3

Trial Overview The study tests the effectiveness and safety of SCD-044 in three different doses compared to a placebo. Participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting in this Phase II trial.

How Is the Trial Designed?

Group I: SCD-044 Tablets_Dose 1 Active Control 1 Intervention

SCD-044 Tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.

Group II: SCD-044 Tablets_Dose 2 Active Control 1 Intervention

SCD-044 Tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.

Group III: SCD-044 Tablets_Dose 3 Active Control 1 Intervention

SCD-044 Tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.

Group IV: Placebo of SCD-044 product Placebo Group 1 Intervention

Placebo tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.

Who Is Running the Clinical Trial?

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

In a study involving 100 patients with eczema/atopic dermatitis, clocortolone pivalate 0.1% cream was found to be significantly more effective than a placebo in all measured outcomes, both objective and subjective.

The treatment was well-tolerated with no adverse reactions reported, indicating a high level of safety and excellent patient acceptance for both the active and placebo creams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clocortolone pivalate: a paired comparison clinical trial of a new topical steroid in eczema/atopic dermatitis. Rosenthal, AL.[2019]

Citations

1. sunpharma.com sunpharma.com/wp-content/uploads/2025/07/Press-Release-Sun-Pharma-Announces-Top-Line-Results-from-the-Phase-2-Clinical-Trials-Evaluating-SCD-044.pdf

Sun Pharma Announces Top-Line Results from the Phase ... The Phase 2 randomized, double-blind, placebo-controlled study of SCD-044 included 263 people living with moderate to severe plaque psoriasis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04684485

To Assess the Efficacy and Safety of SCD-044 in ... This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic ...

3. geneonline.com geneonline.com/sun-pharma-ends-development-of-psoriasis-and-atopic-dermatitis-drug-scd-044-after-phase-2-trial-failure/

Sun Pharma Ends Development of Psoriasis and Atopic ... The Phase 2 trials aimed to evaluate the effectiveness and safety profile of SCD-044 in treating two chronic skin conditions: psoriasis and ...

4. withpower.com withpower.com/trial/phase-3-dermatitis-atopic-6-2021-1b2bf

SCD-044 for Eczema (SOLARES-AD-1 Trial) In a study involving 100 patients with eczema/atopic dermatitis, clocortolone pivalate 0.1% cream was found to be significantly more effective than a placebo in ...

5. clinicaltrials.eu clinicaltrials.eu/inn/vibozilimod/

Vibozilimod – Application in Therapy and Current Clinical ... For atopic dermatitis: To evaluate the proportion of patients who achieve at least a 75% improvement in the Eczema Area and Severity Index (EASI) score after 16 ...

6. ctv.veeva.com ctv.veeva.com/study/to-assess-the-efficacy-and-safety-of-scd-044-in-the-treatment-of-moderate-to-severe-atopic-dermatiti

To Assess the Efficacy and Safety of SCD-044 in the ... This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.