Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

NCT02975206 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MTI-103
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 52

Brief Summary

Study of the Efficacy, Safety, and Tolerability of Serlopitant for Pruritus (Itch) in Atopic Dermatitis

Conditions

Pruritus; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change in WI-NRS From Baseline to Week 6

  Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.

  Week 6 compared to Baseline

Secondary Outcomes (2)

• WI-NRS 4-point Responder Rate at Week 6

  Week 6 compared to Baseline

• Change in Quality of Life (ItchyQoL) From Baseline to Week 6

  Week 6 compared to Baseline

Study Arms (3)

Serlopitant High Dose

EXPERIMENTAL

serlopitant tablets - high dose

Drug: Serlopitant High Dose

Serlopitant Low Dose

EXPERIMENTAL

serlopitant tablets - low dose

Drug: Serlopitant Low Dose

Placebo Oral Tablet

PLACEBO COMPARATOR

matching placebo tablets

Drug: Placebo Oral Tablet

Interventions

Serlopitant High Dose DRUG

serlopitant tablets - high dose

Serlopitant High Dose

Placebo Oral Tablet DRUG

placebo tablet

Placebo Oral Tablet

Serlopitant Low Dose DRUG

serlopitant tablets - low dose

Serlopitant Low Dose

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 13 years or older
• Pruritus prior to and during the initial screening period
• Diagnosis of atopic dermatitis
• Judged to be in good health in the investigator's opinion

You may not qualify if:

• Prior treatment with study drug or similar drug
• Pruritus due to another reason besides atopic dermatitis
• Presence of any medical condition or disability that could interfere with study
• History of hypersensitivity to serlopitant or any of its components
• Currently pregnant or male partner of pregnant female
• Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (52)

Study Site 332

Anniston, Alabama, United States

Location

Study Site 363

Birmingham, Alabama, United States

Location

Study Site 340

Hoover, Alabama, United States

Location

Study Site 364

Glendale, Arizona, United States

Location

Study Site 334

Cerritos, California, United States

Location

Study Site 386

Encinitas, California, United States

Location

Study Site 366

Fountain Valley, California, United States

Location

Study Site 338

Los Angeles, California, United States

Location

Study Site 383

North Hollywood, California, United States

Location

Study Site 374

Oceanside, California, United States

Location

Study Site 347

San Diego, California, United States

Location

Study Site 356

San Diego, California, United States

Location

Study Site 333

San Francisco, California, United States

Location

Study Site 376

Santa Monica, California, United States

Location

Study Site 358

Denver, Colorado, United States

Location

Study Site 370

Jacksonville, Florida, United States

Location

Study Site 331

Miami, Florida, United States

Location

Study Site 348

Miami, Florida, United States

Location

Study Site 378

Miami, Florida, United States

Location

Study Site 353

Pinellas Park, Florida, United States

Location

Study Site 368

Tampa, Florida, United States

Location

Study Site 377

Tampa, Florida, United States

Location

Study Site 369

Atlanta, Georgia, United States

Location

Study Site 349

Savannah, Georgia, United States

Location

Study Site 381

Chicago, Illinois, United States

Location

Study Site 360

New Albany, Indiana, United States

Location

Study Site 380

Bardstown, Kentucky, United States

Location

Study Site 344

Louisville, Kentucky, United States

Location

Study Site 379

Boston, Massachusetts, United States

Location

Study Site 350

Warren, Michigan, United States

Location

Study Site 371

Saint Joseph, Missouri, United States

Location

Study Site 387

Las Vegas, Nevada, United States

Location

Study Site 352

Berlin, New Jersey, United States

Location

Study Site 375

Forest Hills, New York, United States

Location

Study Site 373

Rochester, New York, United States

Location

Study Site 341

High Point, North Carolina, United States

Location

Study Site 355

Shelby, North Carolina, United States

Location

Study Site 337

Oklahoma City, Oklahoma, United States

Location

Study Site 345

Johnston, Rhode Island, United States

Location

Study Site 362

Providence, Rhode Island, United States

Location

Study Site 382

Anderson, South Carolina, United States

Location

Study Site 343

Spartanburg, South Carolina, United States

Location

Study Site 357

Chattanooga, Tennessee, United States

Location

Study Site 365

Austin, Texas, United States

Location

Study Site 335

Houston, Texas, United States

Location

Study Site 359

Pflugerville, Texas, United States

Location

Study Site 339

Plano, Texas, United States

Location

Study Site 361

San Antonio, Texas, United States

Location

Study Site 351

Draper, Utah, United States

Location

Study Site 342

Norfolk, Virginia, United States

Location

Study Site 336

Richmond, Virginia, United States

Location

Study Site 367

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Pruritus; Dermatitis, Atopic

Interventions

serlopitant

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Anna Gururajan
• Organization: Menlo Therapeutics Inc.

agururajan@menlotx.com

(650) 486-1416

Study Officials

• Mary Spellman, MD

  Vyne Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: January 16, 2018
• Study Completion: February 23, 2018
• Last Updated: May 20, 2021
• Results First Posted: March 5, 2019

Record last verified: 2021-05

Locations

US (52)