IL1-TRAP, Rilonacept, in Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01538719
• Date of registration: 21/02/2012
• Prospective Registration: No
• Primary sponsor: Boston University
• Public title: IL1-TRAP, Rilonacept, in Systemic Sclerosis
• Scientific title: Randomized, Double-Blind, Placebo-Controlled Trial if IL1-TRAP, Rilonacept, in Systemic Sclerosis -A Phase I/II Biomarker Trial
• Date of first enrolment: December 2011
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01538719
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Robert W Simms, MD
• Affiliation: Boston University Medical Center-Rheum/Arthritis Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must meet the American College of Rheumatology criteria for systemic sclerosis with
diffuse cutaneous involvement and < 24 months since the onset of the first SSc
manifestation other than Raynaud's phenomenon; or has had an increase of MRSS by 5 in
the last 6 months.

- Must have a MRSS of = 15.

- Male or female patients = 18 years of age.

- Able and willing to give written informed consent and comply with the requirements of
the study protocol.

Exclusion Criteria:

- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives
of the investigational drug (whichever is longer).

- Ongoing use of high dose steroids (> 10mg/day prednisone or equivalent) or unstable
steroid dose in the past 4 weeks.

- Treatment with immunosuppressive (other than low dose steroids), cytotoxic or
anti-fibrotic drug within 4 weeks of screening.

- The patient has positive viral hepatitis B, hepatitis C or HIV serologies on screening
laboratories. (Patients with a positive hepatitis B surface antibody (HBsAb) test with
a history of prior hepatitis B immunization are eligible as long as other criteria are
met (i.e., negative tests for: hepatitis B surface antigen [HBsAg], hepatitis B core
antibody [HBcAb], and hepatitis C virus antibody [HCVAb]).)

- Known active bacterial, viral fungal mycobacterial, or other infection (including
tuberculosis or atypical mycobacterial disease, but excluding fungal infections of
nail beds) or any major episode of infection requiring hospitalization or treatment
with i.v. antibiotics within 4 weeks of screening.

- Patients must have a negative PPD tested within 6 months of the time of screening, or
past positive PPD treated with appropriate antibiotic prophylaxis.

- Patients with a history of malignancy within the past 5 years.

- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.

- Scleroderma renal crisis within 6 months or creatinine greater than 2.0

- Pregnancy (a negative pregnancy test will be performed for all women of childbearing
potential on study day 0 and 42).

- Male and female patients of child-producing potential must agree to use effective
contraception while enrolled on study and receiving the experimental drug, and for at
least 3 months after the last treatment.

- Nursing mothers

- Gastrointestinal involvement requiring total parenteral nutrition or hospitalization
within the past 3 months for pseudo-obstruction

- Moderately severe pulmonary disease with FVC < 60%, or DLCO < 50% predicted.

- Moderately severe cardiac disease with either a history of significant arrhythmia (not
to include conduction delays other than trifascicular block, or PVCs or PACs <
5/minute), clinically significant heart failure, or unstable angina.

- Hemoglobin: < 8.5 gm/dL

- White blood count < 3,000/mm3 or total neutrophil count < 1,500

- Platelets: < 100,000/mm3

- AST or ALT > 2.5 x Upper Limit of Normal.

- Total bilirubin > 1.5 x upper limit of normal (ULN). Patients with Gilbert's Disease
may be included if their total bilirubin is = 3.0 mg/dL.

- Patients should not have received any live vaccine within 30 days of trial entry

- Patients with a history of rilonacept allergy will be excluded.

- Patients who, in the opinion of the Investigator, have significant medical or
psychosocial problems that warrant exclusion. Examples of significant problems
include, but are not limited to:

- Other serious non-malignancy-associated medical conditions that may be expected to
limit life expectancy or significantly increase the risk of SAEs.

- Any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the
Investigator, would preclude informed consent, consistent follow-up, or compliance
with any aspect of the study

- Current use of TNF-blockers within 4 weeks of screening



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Scleroderma

Diffuse Systemic Sclerosis

Diffuse Scleroderma

Systemic Sclerosis

Intervention(s)

Other: Placebo

Drug: Rilonacept

Primary Outcome(s)

Change in 2- Gene Biomarker [Time Frame: Visit 3 (Day 42) - Visit 1 (Day 0)]

Secondary Outcome(s)

Change in Modified Rodnan Skin Score [Time Frame: Visit 3 (Day 42) - Visit 1 (Day 0)]

Secondary ID(s)

H31332

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 01/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01538719