Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis

NCT00928447 | Completed Phase 2 Results

• 1 other identifier: HALO-114-201
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the prevention and treatment of skin allergic reaction to nickel. The study drug and placebo will be administered by intradermal injection.

Conditions

Dermatitis, Allergic Contact

Keywords

rHuPH20; Recombinant Human hyaluronidase

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 1

  Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (\>= Grade 1) have been reported in this outcome measure.

  Day 3 (48 hours post-dose after the patch removal for Regimen 1) up to Day 14

• Number of Participants With Positive Reaction Scores Based Upon ICDRG Scoring Scale: Regimen 2

  Cutaneous reactions at the patch test sites were scored according to the ICDRG scoring scale as Grade 0 (-)= Negative reaction, Grade 1/2 (?)= Doubtful reaction; faint macular erythema only, Grade 1 (1+)= Weak (nonvesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 2 (2+): Strong (vesicular) positive reaction; erythema, infiltration, papules, vesicles, Grade 3 (3+): Extreme positive reaction; bullous reaction Grade NA (IR): Irritant reaction of different types. Participants with positive reaction scores (\>= Grade 1) have been reported in this outcome measure.

  Day 3 (48 hours post-dose after the patch removal for Regimen 2) up to Day 14

Secondary Outcomes (3)

• Percentage of Participants With a >=1 Grade Change in ICDRG Score in at Least One Patch Region After Treatment With rHuPH20 or Placebo: Regimen 1

  Day 3 (48 hours post-dose after the patch removal for Regimen 1)

• Percentage of Participants With a >=1 Grade Change in ICDRG Score in at Least One Patch Region After Treatment With rHuPH20 or Placebo: Regimen 2

  Day 3 (48 hours post-dose after the patch removal for Regimen 2)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Baseline up to Day 14

Study Arms (2)

rHuPH20

EXPERIMENTAL

Participant's upper back will be divided into 2 equal spaces and will receive Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (NSC) (1, 2.5, or 5%) determined at screening, will be applied to the upper space at Day 1. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. An ID injection containing rHuPH20 (3,000 Units \[U\]) will be administered once daily (QD) for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space will be injected intradermally with drug rHuPH20 (3,000 U) at Day 1. Ten minutes after the injections, patches with the NSC (1, 2.5, or 5%) determined at screening will be applied to the injection sites. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. As during pretreatment, an ID injection containing rHuPH20 will be then administered QD for 5 days.

Drug: rHuPH20

Placebo

PLACEBO COMPARATOR

Participant's upper back will be divided into 2 equal spaces and will receive Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the NSC (1, 2.5, or 5%) determined at screening, will be applied to the upper space at Day 1. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. An ID injection containing placebo will be administered QD for 5 days at the center of each area of reaction. In Regimen 2, a single row of 4 sites in the lower space will be injected intradermally with placebo at Day 1. Ten minutes after the injections, patches with the NSC (1, 2.5, or 5%) determined at screening will be applied to the injection sites. After 48 hours, the patches will be removed and the reactions will be graded on the ICDRG scale. As during pretreatment, an ID injection containing placebo will be then administered QD for 5 days.

Drug: Placebo

Interventions

rHuPH20 DRUG

0.25 milliliter (mL) Intradermal (ID) syringe push bolus injection of rHuPH20

rHuPH20

Placebo DRUG

0.25 mL ID syringe push bolus injection of placebo control

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females 18-60 years of age. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
• Known contact dermatitis to nickel with a confirmed positive patch-test result to nickel sulfate.
• Intact normal skin without potentially obscuring tattoos, acne, dermatitis, pigmentation or lesions on the posterior aspect of the torso (back) in the area intended for allergen testing and dose administration.
• Vital signs (blood pressure \[BP\], heart rate \[HR\], temperature, respiratory rate) within normal range or, if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and sponsor medical monitor that the participant need not be excluded from the study for this reason.
• A negative serum or urine pregnancy test (if female of child-bearing potential) within 14 days of initial study drug administration.
• Participant should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol.
• Decision-making capacity and willingness and ability to comply with the requirements for full completion of the study.
• Signed, written Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent.

You may not qualify if:

• Nickel allergen patch test greater than a ++ reaction.
• Participants who were treated with chemotherapy agents or systemic corticosteroids within the past 3 months.
• Use of topical steroids, antihistamines, or immunosuppressants used near the site of allergen testing/injection within 14 days.
• Use of oral antihistamines within 14 days of study conduct.
• Extensive ongoing outbreaks of contact dermatitis anywhere on the body.
• Pregnant or women who are breast-feeding.
• Participants with a current disease state that can affect immune response (for example, flu, cancer, human immunodeficiency virus \[HIV\]).
• Known allergy to any hyaluronidase or the ingredients in the dose preparation.
• History of autoimmune disorder.
• Participants with any other medical condition that, in the opinion of the investigator, might significantly affect their ability to safely participate in the study or affect the conduct of this study. Examples might include asthma, diabetes, heart disease, epilepsy, cancer, etc.

Sponsors & Collaborators

• Halozyme Therapeutics: lead

Study Sites (1)

Symbio Phase I Unit, Saint Anthony Memorial Research Center

Michigan City, Indiana, 46360, United States

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Halozyme Therapeutics

halozyme@EVERSANA.com

855-495-3639

Study Officials

• Ikeadi M Ndukwu, M.D., MPH

  Saint Anthony Memorial Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: June 23, 2009
• Primary Completion: September 13, 2009
• Study Completion: September 13, 2009
• Last Updated: December 17, 2021
• Results First Posted: December 17, 2021

Record last verified: 2021-11

Locations

US (1)